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Regulations last checked for updates: Nov 22, 2024
Title 21 - Food and Drugs last revised: Nov 19, 2024
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Title 21
Chapter I
Part 870
Subpart C - Subpart C—Cardiovascular Monitoring Devices
§ 870.2050 - Biopotential amplifier and signal conditioner.
§ 870.2060 - Transducer signal amplifier and conditioner.
§ 870.2100 - Cardiovascular blood flowmeter.
§ 870.2120 - Extravascular blood flow probe.
§ 870.2200 - Adjunctive cardiovascular status indicator.
§ 870.2210 - Adjunctive predictive cardiovascular indicator.
§ 870.2220 - Adjunctive hemodynamic indicator with decision point.
§ 870.2300 - Cardiac monitor (including cardiotachometer and rate alarm).
§ 870.2310 - Apex cardiograph (vibrocardiograph).
§ 870.2320 - Ballistocardiograph.
§ 870.2330 - Echocardiograph.
§ 870.2340 - Electrocardiograph.
§ 870.2345 - Electrocardiograph software for over-the-counter use.
§ 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.
§ 870.2785 - Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
§ 870.2786 - Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
§ 870.2790 - Photoplethysmograph analysis software for over-the-counter use.
§ 870.2800 - Medical magnetic tape recorder.
§ 870.2810 - Paper chart recorder.
§ 870.2840 - Apex cardiographic transducer.
§ 870.2850 - Extravascular blood pressure transducer.
§ 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.
§ 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.
authority:
21 U.S.C. 351
,
360
,
360
c,
360
e,
360
j,
360
source:
45 FR 7907, Feb. 5, 1980, unless otherwise noted.
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