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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
1 868.5630 Nebulizer 霧化治療器 II
Clinical
2 862.1065 Ammonia Test System 氨測試系統 I
3 862.1113 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
4 862.1150 Calibrator 比對標準品 II
5 862.1155 Human Chorionic Gonadotropin (Hcg) Test System 人類絨毛膜性腺激素試驗系統 II
6 862.1160 Bicarbonate/Carbon Dioxide Test System 二氧化碳測試系統 II
7 862.1170 Chloride Test System 氯化物試驗系統 II
8 862.1225 Creatinine Test System 肌氨酸酐試驗系統 II
9 862.1310 Galactose Test System 半乳糖試驗系統 I
10 862.1340 Urinary Glucose (Nonquantitative) Test System 尿中血糖(非量化)測試系統 II
11 862.1345 Glucose Test System 血糖測試系統 II
12 862.1410 Iron (Non-Heme) Test System 鐵(非原血紅素)測試系統 I
13 862.1415 Iron-Binding Capacity Test Binding 鐵結合能力測試系統 I
14 862.1495 Magnesium Test System 鎂測試系統 I
15 862.1580 Phosphorus (Inorganic) Test System 亞磷酸(無機)測試系統 I
16 862.1600 Potassium Test System 鉀測試系統 II
17 862.1660 Quality Control Material (Assayed And Unassay) 品管物質(分析與非分析) I
18 862.1665 Sodium Test System 鈉測試系統 II
19 862.1680 Testosterone Test System 睪固酮試驗系統 I
20 862.1730 Free Tyrosine Test System 游離酥氨基酸試驗系統 I
21 862.1770 Urea Nitrogen Test System 尿素測試系統 II
22 862.1775 Uric Acid Test System 尿酸測試系統 I
Cardiovascular
23 870.1120 Blood Pressure Cuff 壓脈帶式血壓計 II
24 870.1130 Noninvasive Blood Pressure Measurement System 非侵入式血壓量測系統 II
25 870.2300 Cardiac Monitor (Including Cardiotachometer And Rate Alarm) 心臟監視器(心音、心跳警告功能) II
26 870.2330 Echocardiograph 超音波心臟照影計 II
27 870.2340 Electrocardiograph 心電圖機 II
28 870.2350 Electrocardiograph Lead Switching Adaptor 心電圖導程切換接頭 II
29 870.2360 Electrocardiograph Electrode 心電圖機電極片 II
30 870.2370 Electrocardiograph Surface Electrode Tester 心電圖用體表電極測試器 II
31 870.2880 Ultrasonic Transducer 超音波換能器 II
Dental
32 872.1800 Extraoral Source X-Ray System 口腔外X光機 II
33 872.1810 Intraoral Source X-Ray System 口腔內X光機 II
34 872.3060 Gold Based Alloys And Precious Metal Alloys For Clinical Use 牙科使用黃金基底合金和貴重金屬合金 II
35 872.3200 Resin Tooth Bonding Agent 樹脂牙黏著劑 II
36 872.3275 Dental Cement 牙科補泥 II
37 872.3660 Impression Material 牙模材料 II
38 872.3690 Tooth Shade Resin Material 補牙材料 II
39 872.3700 Dental Mercury (U.S.P) 牙科用汞齊 I
40 872.3710 Base Metal Alloy 基底金屬合金 II
41 872.4200 Dental Handpieces And Accessories 牙科手持工具及附件 I
42 872.6250 Chair With A Unit 牙科用椅及附件 I
43 872.6640 Dental Operative Unit 牙科手術器械及附件 I
44 872.6710 Boiling Water Sterilizer 沸水消毒鍋 I
Gastroenterology
45 876.1075 Gastroenterology-Urology Biopsy Instrument 腸胃科-泌尿科切片器械 II
46 876.1500 Endoscope And Accessories 內視鏡及附件 II
47 876.4300 Endoscopic Electrosurgical Unit And Accessories 內視鏡用電刀及其附件 II
48 876.4480 Electrohydraulic Lithotriptor 水震波碎石機 II
49 876.4500 Mechanical Lithotriptor 機械碎石機 II
50 876.4620 Ureteral Stent 輸尿管支架 II
51 876.5010 Biliary Catheter And Accessories 膽導管及附件 II
52 876.5130 Urological Catheter And Accessories 泌尿導管及附件 II
53 876.5160 Urological Clamps For Males 男性尿道夾 I
54 876.5320 Nonimplanted Electrical Continence Device 非植入式電子排尿自制器材 II
55 876.5665 Water Purification System For Dialysis 血液透析用的水淨化系統 II
General Hospital
56 880.2910 Clinical Electronic Thermometer 電子式體溫計 II
57 880.5090 Liquid Bandage 液體性繃帶 I
58 880.5200 Intravascular Catheter 血管內導管 II
59 880.5400 Neonatal Incubator 新生兒保溫箱 II
60 880.5410 Neonatal Transport Incubator 可攜式新生兒保溫箱 II
61 880.5440 Intravascular Administration Set 血管內輸液套 II
62 880.5570 Hypodermic Single Lumen Needle 皮下注射單管腔針頭 II
63 880.5680 Pediatric Position Holder 小兒姿勢固定器 I
64 880.5725 Infusion Pump 輸液幫浦 II
65 880.5860 Piston Syringe 注射針筒 II
66 880.6250 Patient Examination Glove 醫檢手套 I
67 880.6375 Patient Lubricant 病患用潤滑劑 I
68 880.6760 Protective Restraint 保護性限制束帶 I
69 880.6880 Steam Sterilizer 蒸氣消毒鍋 II
70 880.6885 Liquid Chemical Sterilants/High Level Disinfectants 化學液體滅菌劑 II
Microbiology
71 866.1620 Antimicrobial Susceptibility Test Disc 抗菌感受性試驗盤 II
72 866.1640 Antimicrobial Susceptibility Test Powder 抗菌感受性試驗粉末 II
73 866.2390 Transport Culture Medium 輸送培養基 I
74 866.2560 Microbial Growth Monitor 微生物生長監視器 I
75 866.2850 Automated Zone Reader 自動區域判讀器 I
76 866.2900 Microbiological Specimen Collection And Transport Device 微生物樣本收集及輸送器材 I
77 866.3110 Campylobacter Fetus Serological Reagents 胎兒彎曲畸形菌屬血清試劑 I
78 866.3120 Chlamydia Serological Reagents 披衣菌血清試劑 I
79 866.3235 Epstein-Barr Virus Serological Reagents EB病毒血清試劑 I
80 866.3370 Mycobacterium Tuberculosis Immunofluorescent Reagents 結核桿菌免疫螢光試劑 I
81 866.3870 Trypanosoma Spp. Serological Reagents 錐虫血清試劑 I
Neurology
82 882.1030 Ataxiagraph 運動機能失調描記器 I
83 882.1240 Echoencephalograph 超音波腦波儀 II
84 882.1310 Cortical Electrode 皮質電極 II
85 882.1400 Electroencephalograph 腦電位計 II
86 882.1420 Electroencephalogram (Eeg) Signal Spectrum Analyzer 腦電位計頻譜分析儀 I
87 882.1480 Neurological Endoscope 神經科用內視鏡 II
88 882.4060 Ventricular Cannula 腦室套管 I
89 882.4545 Shunt System Implantation Instrument 分流系統植入用器械 I
90 882.5890 Transcutaneous Electrical Nerve Stimulator For Pain Relief 減輕疼痛用經皮神經電刺激器 II
Obstetrics/Gynecology
91 884.1690 Hysteroscope And Accessories 子宮鏡及附件 II
92 884.1700 Hysteroscopic Insufflator 子宮鏡灌入器 II
93 884.1720 Gynecologic Laparoscope And Accessories 婦科用腹腔鏡及附件 II
94 884.1730 Laparoscopic Insufflator 腹腔鏡灌入器 II
95 884.2225 Obstetric-Gynecologic Ultrasonic Imager 婦產科用超音波掃瞄儀 II
96 884.2660 Fetal Ultrasonic Monitor And Accessories 胎兒超音波監視器及附件 II
97 884.2960 Obstetric Ultrasonic Transducer And Accessories 產科用超音波換能器及附件 II
98 884.2980 TELETHERMOGRAPHIC SYSTEM 遠距溫度描記系統 I
99 884.2982 Liquid Crystal Thermographic System 液晶溫度描記系統 I
100 884.4120 Gynecologic Electrocautery And Accessories 婦產科電燒刀及其附件 II
101 884.4550 Gynecologic Surgical Laser 婦科手術用雷射 II
102 884.5300 Condom 衛生套 II
103 884.5310 Condom With Spermicidal Lubricant 附殺精劑之衛生套 II
104 884.5460 Scented Or Scented Deodorized Menstrual Tampon 具香味或除臭的衛生棉塞 II
105 884.5470 Unscented Menstrual Tampon 無香味的衛生棉塞 II
106 884.6100 Assisted Reproduction Needle 輔助生殖之導引針 II
107 884.6110 Assisted Reproduction Catheter 輔助生殖導管 II
108 884.6120 Assisted Reproduction Accessory 輔助生殖附件 II
109 884.6130 Assisted Reproduction Microtools 輔助生殖之顯微器具 II
110 884.6140 Assisted Reproduction Microtool Fabrication Instrumentation 輔助生殖之微吸管製造器械 II
111 884.6150 Assisted Reproduction Micromanipulators And Microinjectors 輔助生殖顯微之控制及注射器材 II
112 884.6160 Assisted Reproduction Labware 輔助生殖用之實驗室器材 II
113 884.6180 Reproductive Media And Supplements 生殖用培養基及補充物 II
114 884.6190 Assisted Reproduction Microscope And Microscope Accessories 輔助生殖顯微鏡及其附件  
Ophthalmic
115 886.1570 Ophthalmoscope-2 Classes 眼底鏡 II
116 886.1780 Retinoscope 視網膜鏡 II
117 886.1850 Ac-Powered Slit-Lamp Biomicroscope 交流電力式細隙燈 II
118 886.3400 Keratoprosthesis 角膜彌補物 II
119 886.4070 Powered Corneal Burr 動力式角膜鑽孔器 I
120 886.4150 Vitreous Aspiration And Cutting Instrument 玻璃體吸引及切割器械 II
121 886.4300 Intraocular Lens Guide 人工水晶體導引器 I
122 886.4370 Keratome 角膜刀 I
123 886.4390 Ophthalmic Laser 眼科雷射器材 II
124 886.4392 Nd: Yag Laser For Posterior Capsulotomy 後囊切除用釹-雅各雷射 II
125 886.4670 Phacofragmentation System 晶體乳化儀 II
126 886.5916 Rigid Gas Permeable Contact Lens 硬式透氣隱形眼鏡 II
127 886.5918 Rigid Gas Permeable Contact Lens Car Products 硬式透氣隱形眼鏡保存用產品 II
128 886.5925 Soft (Hydrophilic) Contact Lens 軟式隱形眼鏡 II
129 886.5928 Soft (Hydrophylic) Contact Lens Care Products 軟式隱形眼鏡維護產品  
Physical Medicine
130 890.1385 Diagnostic Electromyograph Needle Electrode 診斷用肌電圖針電極 II
131 890.3800 Motorized Three-Wheeled Vehicle 醫療用電動三輪車 II
132 890.3850 Mechanical Wheelchair 手動輪椅 I
133 890.3860 Powered Wheelchair 電動輪椅 II
134 890.3880 Special Grade Wheelchair 特製輪椅 II
135 890.3900 Standup Wheelchair 站立式輪椅 II
136 890.5100 Immersion Hydrobath 浸泡式水浴 II
137 890.5500 Infrared Lamp 紅外線燈 II
138 890.5710 Hot Or Cold Disposable Pack 拋棄式冷熱敷袋 I
139 890.5850 Powered Muscle Stimulator 動力式肌肉刺激器 II
Radiology
140 892.1000 Magnetic Resonance Diagnostic Device 磁振診斷器材 II
141 892.1100 Scintillation Gamma Camera Γ閃爍攝影機 I
142 892.1110 Positron Camera 正子攝影機 I
143 892.1200 Emission Computed Tomography System 放射電腦斷層掃描系統 II
144 892.1310 Nuclear Tomographic System 核醫斷層掃描系統 II
145 892.1360 Radionuclide Dose Calibrator 放射核種劑量校準儀 II
146 892.1540 Nonfetal Ultrasonic Monitor 非胎兒超音波監視器 II
147 892.1550 Ultrasonic Pulsed Doppler Imaging System 超音波都卜勒影像系統 II
148 892.1560 Ultrasonic Pulsed Echo Imaging System Diagnostic 超音波影像系統 II
149 892.1570 Ultrasonic Transducer 診斷用超音波換能器 II
150 892.1600 Angiographic X-Ray System X光血管攝影系統 II
151 892.1610 Diagnostic X-Ray Beam Limiting Device 診斷用X光遮光器 II
152 892.1620 Cine Or Spot Fluorographic X-Ray Camera 連續或間斷式透視X光攝影機 II
153 892.1630 Electrostatic X-Ray Imaging System 靜電式X光影像系統 II
154 892.1650 Image-Intensified Fluoroscopic X-Ray System 透視型X光系統 II
155 892.1670 Spot Film Device 畫面分割攝影器材 II
156 892.1680 Stationary X-Ray System 固定式X光系統 II
157 892.1710 Mammographic X-Ray System 乳房X光照射系統 II
158 892.1720 Mobile X-Ray System 移動式X光系統 II
159 892.1740 Tomographic X-Ray System X光斷層掃描系統 II
160 892.1750 Computed Tomography X-Ray System 電腦斷層掃描系統 II
161 892.1820 Pneumoencephalographic Chair 充氣腦X光攝影用椅 II
162 890.1850 Radiographic Film Cassette 放射線影片匣 II
163 892.1870 Radiographic Film/Cassette Changer Programmer 放射線影片/換片匣之設定器 II
164 892.1900 Automatic Radiographic-Film Processor 自動式放射線影片處理器 II
165 892.2030 Medical Image Digitizer 醫學影像數位器 II
166 892.2040 Medical Image Hardcopy Device 醫學影像列印裝置 II
167 892.2050 Picture Archiving And Communications Systems 醫學圖像紀錄傳輸系統 II
General & Plastic Surgery
168 878.4400 Electrosurgical Cutting And Coagulation Device And Accessories 切割及止血用電刀及其附件 II
169 878.4460 Surgeon's Gloves 手術手套 I
170 878.4580 Surgical Lamp 手術燈 II
171 878.4780 Powered Suction Pump 電動抽吸幫浦 II
172 878.4810 Laser Surgical Instrument For Use In General & Plastic Surgery & In Dermatology 一般外科、整形外科及皮膚科用雷射儀 II
Toxicology
173 862.3050 BREATH-ALCOHOL TEST SYSTEM 呼氣酒精測試系統 I
174 862.3100 Amphetamine Test System 安非他命試驗系統 II
175 862.3110 Antimony Test System 銻試驗系統 I
176 862.3120 Arsenic Test System 砷試驗系統 I
177 862.3200 Clinical Toxicology Calibrator 臨床毒物學校正器 II
178 862.3220 Carbon Monoxide Test System 一氧化碳試驗系統 I
179 862.3240 Cholinesterase Test System 膽素酯酵素試驗系統 I
180 862.3250 Cocaine And Cocaine Metabolite Test System 可卡因及其代謝物試驗系統 II
181 862.3270 Codeine Test System 可待因試驗系統 II
182 862.3280 Clinical Toxicology Control Material 臨床毒物學控制工具 I
183 862.3600 Mercury Test System 汞試驗系統 I
184 862.3610 Methamphetamine Test System 甲基安非他命試驗系統 II
185 862.3620 Methadone Test System 美沙酮試驗系統 II
186 862.3640 Morphine Test System 嗎啡試驗系統 II
187 862.3650 Opiate Test System 鴉片試驗系統 II
188 862.3750 Quinine Test System 奎寧試驗系統 I
189 862.3850 Sulfonamide Test System 磺胺試驗系統 I
190 862.3870 Cannabinoid Test System 大麻試驗系統 II
191 UNCLASSIFIED Phencyclidine (Pcp) Test System:Thin Layer Chromatography 天使塵試驗系統:薄層層析法  
192 UNCLASSIFIED Phencyclidine (Pcp) Test System:Radioimmunoassay 天使塵試驗系統:輻射免疫分析法  
193 UNCLASSIFIED Phencyclidine (Pcp) Test System:Enzyme Immunoassay 天使塵試驗系統:酵素免疫分析法