- 讲师:刘萍萍 / 谢楠
- 课时:160h
- 价格 4580 元
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A亚部--总则(General Provisions)
870.1
范围
870.3
Effective dates of requirement for premarket approval
870.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
B亚部--心血管诊断器械(Cardiovascular Diagnostic Devices)
870.1025
心律失常探测器和警报器(包括ST段测量和警报)
870.1100
Blood pressure alarm
870.1110
Blood pressure computer
870.1120
Blood pressure cuff
870.1130
Noninvasive blood pressure measurement system
870.1140
Venous blood pressure manometer
870.1200
Diagnostic intravascular catheter
870.1210
Continuous flush catheter
870.1220
Electrode recording catheter or electrode recording probe
870.1230
Fiberoptic oximeter catheter
870.1240
Flow-directed catheter
870.1250
Percutaneous catheter
870.1270
Intracavitary phonocatheter system
870.1280
Steerable catheter
870.1290
Steerable catheter control system
870.1300
Catheter cannula
870.1310
Vessel dilator for percutaneous catheterization
870.1330
Catheter guide wire
870.1340
Catheter introducer
870.1350
Catheter balloon repair kit
870.1360
Trace microsphere
870.1370
Catheter tip occluder
870.1380
Catheter stylet
870.1390
Trocar
870.1425
Programmable diagnostic computer
870.1435
Single-function, preprogrammed diagnostic computer
870.1450
Densitometer
870.1650
Angiographic injector and syringe
870.1660
Indicator injector
870.1670
Syringe actuator for an injector
870.1750
External programmable pacemaker pulse generator
870.1800
Withdrawal-infusion pump
870.1875
Stethoscope
870.1915
Thermodilution probe
C亚部--心血管监测器械(Cardiovascular Monitoring Devices)
870.2050
生物电位放大器和信号调节器
870.2060
Transducer signal amplifier and conditioner
870.2100
Cardiovascular blood flowmeter
870.2120
Extravascular blood flow probe
870.2300
Cardiac monitor (including cardiotachometer and rate alarm)
870.2310
Apex cardiograph (vibrocardiograph)
870.2320
Ballistocardiograph
870.2330
Echocardiograph
870.2340
Electrocardiograph
870.2350
Electrocardiograph lead switching adaptor
870.2360
Electrocardiograph electrode
870.2370
Electrocardiograph surface electrode tester
870.2390
Phonocardiograph
870.2400
Vectorcardiograph
870.2450
Medical cathode-ray tube display
870.2600
Signal isolation system
870.2620
Line isolation monitor
870.2640
Portable leakage current alarm
870.2675
Oscillometer
870.2700
Oximeter
870.2710
Ear oximeter
870.2750
Impedance phlebograph
870.2770
Impedance plethysmograph
870.2780
Hydraulic, pneumatic, or photoelectric plethysmographs
870.2800
Medical magnetic tape recorder
870.2810
Paper chart recorder
870.2840
Apex cardiographic transducer
870.2850
Extravascular blood pressure transducer
870.2860
Heart sound transducer
870.2870
Catheter tip pressure transducer
870.2880
Ultrasonic transducer
870.2890
Vessel occlusion transducer
870.2900
Patient transducer and electrode cable (including connector)
870.2910
Radiofrequency physiological signal transmitter and receiver
870.2920
Telephone electrocardiograph transmitter and receiver
D亚部--心血管修复器械(Cardiovascular Prosthetic Devices)
870.3250
Vascular clip
870.3260
Vena cava clip
870.3300
Arterial embolization device
870.3375
Cardiovascular intravascular filter
870.3450
Vascular graft prosthesis
870.3470
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
870.3535
Intra-aortic balloon and control system
870.3545
责编:李亚林
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