量測中心醫療器材驗證室─510(k)受理審查項目

510(k)受理審查項目

服務項目 > 510(k) > 510(k)受理審查項目

Panel		CFR Number	Regulation Name/Device Name	Class
Anesthesiology(2)
1		868.544	Portable oxygen generator. 手提式氧氣產生器	II
2		868.5915	Manual emergency ventilator. 手動緊急呼吸器	II
Clinical Chemistry (25)
3		862.1050	Alkaline phosphatase or isoenzymes test system. 鹼性磷酸酶或同功酶試驗系統	II
4		862.1065	Ammonia test system. 血氨試驗系統	I
5		862.1110	Bilirubin (total or direct) test system. 膽紅素(總量或直接的)試驗系統	II
6		862.1113	Bilirubin (total and unbound) in the neonate test system. 新生兒膽紅素(總量及未結合的)試驗系統	I
7		862.1120	Blood gases (PCO2, PO2) and blood pH test system. 血內氣體(PCO2,PO2)及血液pH值試驗系統	II
8		862.1155	Human chorionic gonadotropin (HCG) test system. 人絨毛膜促性腺激素試驗系統	II
9		862.1160	Bicarbonate/carbon dioxide test system. 重碳酸鹽/二氧化碳試驗系統	II
10		862.1170	Chloride test system. 氯化物試驗系統	II
11		862.1225	Creatinine test system. 肌氨酸酐試驗系統	II
12		862.1310	Galactose test system. 半乳糖試驗系統	I
13		862.1340	Urinary glucose (nonquantitative) test system. 尿葡萄糖（非定量）試驗系統	II
14		862.1345	Glucose test system. 葡萄糖試驗系統	II
15		862.1450	Lactic acid test system. 乳酸試驗系統	I
16		862.1475	Lipoprotein test system. 脂蛋白試驗系統	I
17		862.1495	Magnesium test system. 鎂試驗系統	I
18		862.1600	Potassium test system. 鉀試驗系統	II
19		862.1665	Sodium Test System 鈉試驗系統	II
20		862.1675	Blood specimen collection device. 血液樣本收集設備	II
21		862.1680	Testosterone test system. 睪丸脂酮試驗系統	I
22		862.1690	Thyroid stimulating hormone test system. 甲狀腺剌激荷爾蒙試驗系統	II
23		862.1695	Free thyroxine test system. 游離甲狀腺素試驗系統	II
24		862.1730	Free tyrosine test system. 游離酥氨基酸試驗系統	I
25		862.1770	Urea nitrogen test system. 尿素氮試驗系統	II
26		862.1775	Uric acid test system. 尿酸試驗系統	I
27		862.1825	Vitamin D test system. 維他命D試驗系統	II
Hematology (4)
28		864.5220	Automated differential cell counter. 自動區別細胞計數器	II
29		864.5425	Multipurpose system for in vitro coagulation studies 體外凝集研究之多功能系統	II
30		864.5700	Automated platelet aggregation system 自動血小板凝集系統	II
31		864.6550	Occult blood test 潛血試驗	II
Cardiovascular (9)
32		870.1120	Blood pressure cuff. 血壓壓脈帶	II
33		870.1130	Noninvasive blood pressure measurement system. 非侵入性血壓測量系統	II
34		870.2300	Cardiac monitor (including cardiotachometer and rate alarm). 心臟監視器（包含心動數計和心率警示器）	II
35		870.2330	Echocardiograph. 超音波心動描記器	II
36		870.2340	Electrocardiograph. 心電圖描記器	II
37		870.2350	Electrocardiograph lead switching adaptor. 心電圖導程切換接頭	II
38		870.2700	Oximeter. 血氧飽和測定儀	II
39		870.2370	Electrocardiograph surface electrode tester. 心電圖表面用電極	II
40		870.2880	Ultrasonic transducer. 超音波轉換器	II
Dental (12)
41		872.1800	Extraoral source x-ray system. 口腔外X光照射系統	II
42		872.1810	Intraoral source x-ray system. 口腔內X光照射系統	II
43		872.3200	Resin tooth bonding agent. 樹脂牙黏劑	II
44		872.3275	Dental cement. 牙科用水泥	II
45		872.3660	Impression material. 印模材料	II
46		872.3690	Tooth shade resin material. 樹脂牙材	II
47		872.4200	Dental handpiece and accessories. 牙科手機及其附件	I
48		872.4850	Ultrasonic scaler. 超音波洗牙機	I
49		872.6070	Ultraviolet activator for polymerization. 聚合用紫外線活化器	II
50		872.6250	Dental chair and accessories. 牙科治療椅及其附件	I
51		872.6640	Dental operative unit and accessories. 牙科手術裝置及其附件	I
52		872.6710	Boiling water sterilizer. 水熱式滅菌器	I
Gastroenterology (14)
53		876.1075	Gastroenterology-urology biopsy instrument. 腸胃科-泌尿科生檢器械	I
54		876.1075	Gastroenterology-urology biopsy instrument. 腸胃科-泌尿科生檢器械	II
55		876.1500	Endoscope and accessories. 腸胃科-泌尿科生檢器械	II
56		876.4300	Endoscopic electrosurgical unit and accessories. 內視鏡及其附件	II
57		876.4480	Electrohydraulic lithotriptor. 內視鏡用電刀裝置及其附件	II
58		876.4500	Mechanical lithotriptor. 電動液壓碎石儀	II
59		876.4620	Ureteral stent. 機械式碎石器	II
60		876.5010	Biliary catheter and accessories. 輸尿管支架	II
61		876.5130	Urological catheter and accessories. 泌尿導管和其附件	I
62		876.5320	Nonimplanted electrical continence device. 非植入式電子排尿自制裝置	II
63		876.5540	Blood access device and accessories. 血液通路裝置及其附件	I
64		876.5540	Blood access device and accessories. 血液通路裝置及其附件	II
65		876.5665	Water purification system for hemodialysis. 透析用水之淨化系統	II
66		876.5820	Hemodialysis system and accessories. 血液透析系統及其附件	II
General Hospital (14)
67		880.2910	Clinical electronic thermometer. 臨床電子體溫計	II
68		880.5090	Liquid bandage. 液體性繃帶	I
69		880.5200	IIntravascular catheter. 血管內導管	II
70		880.5400	Neonatal incubator. 新生兒保溫箱	II
71		880.5410	Neonatal transport incubator. 新生兒運輸式保溫箱	II
72		880.5440	Intravascular administration set. 血管內輸液套	II
73		880.5570	Hypodermic single lumen needle. 皮下單腔針	II
74		880.5680	Pediatric position holder. 小兒姿勢固定器	I
75		880.5860	Piston syringe. 活塞式注射器	II
76		880.6250	Non-powdered patient examination glove. 無粉病患檢查用手套	I
77		880.6375	Patient lubricant. 病患用潤滑劑	I
78		880.6850	Sterilization wrap. 滅菌包	II
79		880.6880	Steam sterilizer. 蒸氣滅菌器	II
80		880.6885	Liquid chemical sterilants/high level disinfectants. 液體化學性殺菌劑/高度消毒劑	II
Microbiology (11)
81		866.1620	Antimicrobial susceptibility test disc. 抗菌感受性試驗盤	II
82		866.1640	Antimicrobial susceptibility test powder. 抗菌感受性試驗粉末	II
83		866.2390	Transport culture medium. 輸送培養基	I
84		866.2560	Microbial growth monitor. 微生物生長監視器	I
85		866.2850	Automated zone reader. 自動環判讀機	I
86		866.2900	Microbiological specimen collection and transport device. 微生物標本收集及輸送器材	I
87		866.3110	Campylobacter fetus serological reagents. 胎兒彎曲桿菌屬血清試劑	I
88		866.3120	Chlamydia serological reagents. 披衣菌血清試劑	I
89		866.3235	Epstein-Barr virus serological reagents. Epstein-Barr EB病毒血清試劑	I
90		866.3370	Mycobacterium tuberculosis immunofluorescent reagents. 結核桿菌免疫螢光試劑	I
91		866.3870	Trypanosoma spp. serological reagents. 錐蟲屬血清試劑	I
Immnuology (5)
92		866.5270	C-reactive protein immunological test system C反應蛋白免疫試驗系統	II
93		866.5340	Ferritin immunological test system 鐵蛋白免疫試驗系統	II
94		866.5600	Low-density lipoprotein immunological test system 低密度脂蛋白免疫試驗系統	II
95		866.5775	Rheumatoid factor immunological test system. 類風濕性因子免疫試驗系統	II
96		866.5880	Transferrin immunological test system. 運鐵蛋白免疫試驗系統	II
Neurology (7)
97		882.1030	Ataxiagraph. 運動機能失調描記器	I
98		882.1240	Echoencephalograph. 超音波腦波描記器	II
99		882.1310	Cortical electrode. 皮質電極	II
100		882.1320	Cutaneous electrode. 皮膚電極	II
101		882.1400	Electroencephalograph. 腦波描記器	II
102		882.1420	Electroencephalogram (EEG) signal spectrum analyzer. 腦波圖信號頻譜分析儀	I
103		882.5890	Transcutaneous electrical nerve stimulator for pain relief. 疼痛舒緩用經皮神經電刺激器	II
Obstetrics/Gynecology (19)
104		884.1690	Hysteroscope and accessories. 子宮鏡及其附件	II
105		884.1700	Hysteroscopic insufflator. 子宮鏡灌入器	II
106		884.1720	Gynecologic laparoscope and accessories. 婦產科用腹腔鏡及其附件	II
107		884.1730	Laparoscopic insufflator. 腹腔鏡灌入器	I
108		884.2225	Obstetric-gynecologic ultrasonic imager. 婦產科超音波影像設備	II
109		884.2660	Fetal ultrasonic monitor and accessories. 胎兒超音波監視器及其附件	II
110		884.2960	Obstetric ultrasonic transducer and accessories. 產科超音波轉換器及其附件	II
111		884.4120	Gynecologic electrocautery and accessories. 婦產科電燒灼器及其附件	II
112		884.4550	Gynecologic surgical laser. 婦科手術用雷射	II
113		884.5300	Condom. 衛生套(保險套)	II
114		884.5310	Condom with spermicidal lubricant. 含殺精劑的衛生套	II
115		884.5460	Scented or scented deodorized menstrual tampon. 具香味或除臭的衛生棉塞	II
116		884.5470	Unscented menstrual tampon. 無香味的衛生棉塞	II
117		884.6100	Assisted reproduction needles. 輔助生殖之導引針	II
118		884.6110	Assisted reproduction catheters. 輔助生殖導管	II
119		884.6120	Assisted reproduction accessories. 輔助生殖附件	II
120		884.6130	Assisted reproduction microtools. 輔助生殖之微小器具	II
121		884.6140	Assisted reproduction micropipette fabrication instruments. 輔助生殖之微吸管製造器械	II
122		884.6160	Assisted reproduction labware. 輔助生殖用之實驗室器物	II
Ophthalmic (13)
123		886.1570	Ophthalmoscope. 眼底鏡	II
124		886.1850	AC-powered slitlamp biomicroscope. 交流電力式細隙燈	II
125		886.3400	Keratoprosthesis. 角膜彌補物	II
126		886.4150	Vitreous aspiration and cutting instrument. 玻璃體吸引及切割器械	II
127		886.4300	Intraocular lens guide. 人工水晶體導引器	I
128		886.4370	Keratome. 角膜刀	I
129		886.4390	Ophthalmic laser. 眼科雷射裝置	II
130		886.4392	Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. Nd:YAG 後囊切除和外周虹膜切除用Nd:YAG 雷射	II
131		886.4670	Phacofragmentation system. 晶體乳化儀	II
132		886.5916	Rigid gas permeable contact lens. 硬性透氣隱形眼鏡	II
133		886.5918	Rigid gas permeable contact lens care products. 硬性透氣隱形眼鏡保存用產品	II
134		886.5925	Soft (hydrophilic) contact lens. 軟式隱形眼鏡	II
135		886.5928	Soft (hydrophilic) contact lens care products. 軟式隱形眼鏡保存用產品	II
Physical Medicine (9)
136	890.1385		DDiagnostic electromyograph needle electrode. 診斷用肌電圖針電極	II
137	890.3800		Motorized three-wheeled vehicle. 電動三輪車	II
138	890.3850		Mechanical wheelchair. 機械式輪椅	I
139	890.3860		Powered wheelchair. 動力式輪椅	II
140	890.3880		Special grade wheelchair. 特製輪椅	II
141	890.3900		Standup wheelchair. 站立式輪椅	II
142	890.5500		Infrared lamp. 紅外線燈	II
143	890.5710		Hot or cold disposable pack. 醫療用可丟棄式的冷熱敷包	I
144	890.5850		Powered muscle stimulator. 動力式肌肉刺激器	II
Radiology (19)
145		892.1000	Magnetic resonance diagnostic device. 磁振診斷裝置	II
146		892.1100	Scintillation (gamma) camera. 閃爍（伽馬）攝影機	I
147		892.1110	Positron camera. 正子攝影機	I
148		892.1200	Emission computed tomography system. 放射電腦斷層掃描系統	II
149		892.1310	Nuclear tomography system. 核醫斷層掃描系統	II
150		892.1360	Radionuclide dose calibrator. 放射核種劑量校準儀	II
151		892.1540	Nonfetal ultrasonic monitor. 非新生兒超音波監視器	II
152		892.1550	Ultrasonic pulsed doppler imaging system. 超音波脈動都卜勒式影像系統	II
153		892.1560	Ultrasonic pulsed echo imaging system. 超音波回音影像系統	II
154		892.1570	Diagnostic ultrasonic transducer. 診斷用超音波轉換器	II
155		892.1620	Cine or spot fluorographic x-ray camera. 連續或間斷式透視X光機	II
156		892.1630	Electrostatic x-ray imaging system. 靜電式X光影像系統	II
157		892.1650	Image-intensified fluoroscopic x-ray system. 透視X光影像增感管	II
158		892.1680	Stationary x-ray system. 固定式 X 光系統	II
159		892.1710	Mammographic x-ray system. 乳房 X 光系統	II
160		892.1720	Mobile x-ray system. 移動 X 光系統	II
161		892.1740	Tomographic x-ray system. 斷層掃描 X 光系統	II
162		892.1750	Computed tomography x-ray system. 電腦斷層掃描X光系統	II
163		892.2050	Picture archiving and communications system. 醫學圖像紀錄傳輸系統	II
General & Plastic Surgery (7)
164		878.4040	Surgical apparel. 手術用衣物	II
165		878.4400	Electrosurgical cutting and coagulation device and accessories. 切割及止血用電刀及其附件	II
166		878.4460	Non-powdered surgeon's glove. 無粉手術用手套	I
167		878.4580	Surgical lamp. 外科手術燈	II
168		878.4780	Powered suction pump. 動力式抽吸幫浦	II
169		878.4800	Manual surgical instrument for general use. 一般手術用手動式器械	I
170		878.4810	Laser surgical instrument for use in general and plastic surgery and in dermatology. 一般外科、整形外科及皮膚科用雷射儀	II
Toxicology (16)
171		862.3100	Amphetamine test system. 安非他命試驗系統	II
172		862.3110	Antimony test system. 銻試驗系統	I
173		862.3120	Arsenic test system. 砷測試系統	I
174		862.3150	Barbiturate test system. 巴比妥鹽類試驗系統	II
175		862.3250	Cocaine and cocaine metabolite test system. 古柯鹼及其代謝物試驗系統	II
176		862.3270	Codeine test system. 可待因試驗系統	II
177		862.3600	Mercury test system. 汞試驗系統	I
178		862.3610	Methamphetamine test system. 甲基安非他命試驗系統	II
179		862.3620	Methadone test system. 美沙酮試驗系統	II
180		862.3640	Morphine test system. 嗎啡試驗系統	II
181		862.3650	Opiate test system. 鴉片試驗統	II
182		862.3700	Propoxyphene test system. 普帕西芬試驗系統	II
183		862.3750	Quinine test system. 奎寧試驗系統	I
184		862.3850	Sulfonamide test system. 磺胺試驗系統	I
185		862.3870	Cannabinoid test system. 大麻鹼試驗系統	II
186		862.3910	Tricyclic antidepressant drugs test system. 三環抗抑鬱藥試驗系統	II

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