A亚部——无机粘结剂总则(General Provisions)
870.1范围Scope
870.3有关上市前批准生效日期的要求Effective dates of requirement for premarket approval
870.9联邦食品、药品和化妆品法(Federal Food, Drug, and Cosmetic Act,FDCA)第510(k)节的豁免限制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)
Arrhythmia detector and alarm (including ST-segment measurement and alarm)
870.1100血压警报器Blood pressure alarm
870.1110血压计算机Blood pressure computer
870.1120血压袖带门牌制作Blood pressure cuff
870.1130非侵入式血压测量系统Noninvasive blood pressure measurement system
870.1140静脉血压计Venous blood pressure manometer
870.1200诊断用血管内导管Diagnostic intravascular catheter 870.1210连续式冲洗导管Continuous flush catheter
870.1220电极记录导管或电极记录探针Electrode recording catheter or electrode recording probe
870.1230光纤式血氧计导管Fiberoptic oximeter catheter
870.1240导流导管Flow-directed catheter
870.1250经皮导管Percutaneous catheter
870.1270腔内心音导管系统Intracavitary phonocatheter system
870.1280可操纵导管Steerable catheter
870.1290可操纵导管控制系统Steerable catheter control system
870.1300导管套管Catheter cannula
870.1310经皮插入导管用的血管扩张器Vessel dilator for percutaneous catheterization
870.1330导管导线Catheter guide wire
870.1340导管插入器Catheter introducer
870.1350导管球囊修理工具盒Catheter balloon repair kit
870.1360示踪微球体Trace microsphere
870.1370导管尖端封闭器Catheter tip occluder
870.1380导管探针Catheter stylet
涂料过滤器
870.1390套管针Trocar
870.1425可编程的诊断用计算机Programmable diagnostic computer
电厂余热回收 870.1435预编程的单功能诊断用计算机Single-function, preprogrammed diagnostic computer
870.1450光密度计Densitometer csilv
870.1650血管造影注射器和注射管Angiographic injector and syringe
870.1660指示剂注射器Indicator injector
870.1670注射器的注射管制动器Syringe actuator for an injector
870.1750体外可编程起搏器脉冲发生器External programmable pacemaker pulse generator
870.1800抽缩式输液泵Withdrawal-infusion pump
870.1875听诊器Stethoscope
870.1915热稀释探头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Biopotential amplifier and signal conditioner
870.2060传感器信号放大器和调节器Transducer signal amplifier and conditioner 870.2100心血管血液流量计Cardiovascular blood flowmeter
870.2120血管外血流探头Extravascular blood flow probe
870.2300心脏监测器(包括心率计和心率警报器)
Cardiac monitor (including cardiotachometer and rate alarm)
Apex cardiograph (vibrocardiograph)
谐波检测
870.2320心冲击描记器Ballistocardiograph
870.2330超声波心动图仪Echocardiograph
870.2340心电图仪Electrocardiograph
870.2350心电图仪导线转换接合器Electrocardiograph lead switching adaptor
870.2360心电图仪电极Electrocardiograph electrode
870.2370心电图仪表面电极检测器Electrocardiograph surface electrode tester
870.2390心音图仪Phonocardiograph
870.2400心电向量图仪Vectorcardiograph
870.2450医用阴极射线管显示器Medical cathode-ray tube display
870.2600信号隔离系统Signal isolation system
870.2620在线隔离监视器Line isolation monitor
870.2640便携式漏电流警报器Portable leakage current alarm
870.2675动脉搏动描记器Oscillometer
870.2700光电血氧计Oximeter
870.2710耳光电血氧计Ear oximeter
870.2750阻抗式静脉搏动描记器Impedance phlebograph
870.2770阻抗式体积描记器Impedance plethysmograph
870.2780水压式、气动式或光电式体积描记器Hydraulic, pneumatic, or photoelectric plethysmographs
870.2800医用磁带记录器Medical magnetic tape recorder
870.2810纸质图表记录器Paper chart recorder
870.2840尖端心动描记传感器Apex cardiographic transducer
870.2850血管外血压传感器Extravascular blood pressure transducer
870.2860心音传感器Heart sound transducer
870.2870导管顶端压力传感器Catheter tip pressure transducer
870.2880超声式传感器Ultrasonic transducer
870.2890脉管闭塞传感器Vessel occlusion transducer
870.2900患者传感器和电极电缆(包括连接器)
Patient transducer and electrode cable (including connector)
870.2910射频生理信号发送器和接收器Radiofrequency physiological signal transmitter and receiver
870.2920电话式心电图仪发送器和接收器Telephone electrocardiograph transmitter and r
eceiver
D亚部——心血管修复器械(Cardiovascular Prosthetic Devices)
870.3250血管夹Vascular clip
870.3260腔静脉夹Vena cava clip
870.3300动脉栓塞器械Arterial embolization device
870.3375心血管内过滤器Cardiovascular intravascular filter
870.3450血管移植假体Vascular graft prosthesis
870.3470聚丙烯、聚对苯二甲酸乙酯或聚四氟乙烯制成的心内补片或纱布Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene