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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