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Cardiovascular Monitoring Devices
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Medical Devices
Cardiovascular Devices
Cardiovascular Monitoring Devices
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Section
870.2050
Biopotential amplifier and signal conditioner.
Section
870.2060
Transducer signal amplifier and conditioner.
Section
870.2100
Cardiovascular blood flowmeter.
Section
870.2120
Extravascular blood flow probe.
Section
870.2200
Adjunctive cardiovascular status indicator.
Section
870.2210
Adjunctive predictive cardiovascular indicator.
Section
870.2300
Cardiac monitor (including cardiotachometer and rate alarm).
Section
870.2310
Apex cardiograph (vibrocardiograph).
Section
870.2320
Ballistocardiograph.
Section
870.2330
Echocardiograph.
Section
870.2340
Electrocardiograph.
Section
870.2345
Electrocardiograph software for over-the-counter use.
Section
870.2350
Electrocardiograph lead switching adaptor.
Section
870.2360
Electrocardiograph electrode.
Section
870.2370
Electrocardiograph surface electrode tester.
Section
870.2390
Phonocardiograph.
Section
870.2400
Vectorcardiograph.
Section
870.2450
Medical cathode-ray tube display.
Section
870.2600
Signal isolation system.
Section
870.2620
Line isolation monitor.
Section
870.2640
Portable leakage current alarm.
Section
870.2675
Oscillometer.
Section
870.2700
Oximeter.
Section
870.2710
Ear oximeter.
Section
870.2750
Impedance phlebograph.
Section
870.2770
Impedance plethysmograph.
Section
870.2780
Hydraulic, pneumatic, or photoelectric plethysmographs.
Section
870.2790
Photoplethysmograph analysis software for over-the-counter use.
Section
870.2800
Medical magnetic tape recorder.
Section
870.2810
Paper chart recorder.
Section
870.2840
Apex cardiographic transducer.
Section
870.2850
Extravascular blood pressure transducer.
Section
870.2855
Implantable Intra-aneurysm Pressure Measurement System.
Section
870.2860
Heart sound transducer.
Section
870.2870
Catheter tip pressure transducer.
Section
870.2880
Ultrasonic transducer.
Section
870.2890
Vessel occlusion transducer.
Section
870.2900
Patient transducer and electrode cable (including connector).
Section
870.2910
Radiofrequency physiological signal transmitter and receiver.
Section
870.2920
Telephone electrocardiograph transmitter and receiver.