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Title 21

Displaying title 21, up to date as of 7/16/2026. Title 21 was last amended 7/09/2026.
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  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter H —Medical Devices
  4. Part 870 —Cardiovascular Devices
  5. Subpart C   View Full Text
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eCFR Content

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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 870Cardiovascular Devices870.1 – 870.5925
Subpart CCardiovascular Monitoring Devices870.2050 – 870.2920
§ 870.2050Biopotential amplifier and signal conditioner.
§ 870.2060Transducer signal amplifier and conditioner.
§ 870.2100Cardiovascular blood flowmeter.
§ 870.2120Extravascular blood flow probe.
§ 870.2200Adjunctive cardiovascular status indicator.
§ 870.2210Adjunctive predictive cardiovascular indicator.
§ 870.2220Adjunctive hemodynamic indicator with decision point.
§ 870.2300Cardiac monitor (including cardiotachometer and rate alarm).
§ 870.2310Apex cardiograph (vibrocardiograph).
§ 870.2320Ballistocardiograph.
§ 870.2330Echocardiograph.
§ 870.2340Electrocardiograph.
§ 870.2345Electrocardiograph software for over-the-counter use.
§ 870.2350Electrocardiograph lead switching adaptor.
§ 870.2360Electrocardiograph electrode.
§ 870.2370Electrocardiograph surface electrode tester.
§ 870.2390Phonocardiograph.
§ 870.2400Vectorcardiograph.
§ 870.2450Medical cathode-ray tube display.
§ 870.2600Signal isolation system.
§ 870.2620Line isolation monitor.
§ 870.2640Portable leakage current alarm.
§ 870.2675Oscillometer.
§ 870.2700Oximeter.
§ 870.2710Ear oximeter.
§ 870.2750Impedance phlebograph.
§ 870.2770Impedance plethysmograph.
§ 870.2780Hydraulic, pneumatic, or photoelectric plethysmographs.
§ 870.2785Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
§ 870.2786Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
§ 870.2790Photoplethysmograph analysis software for over-the-counter use.
§ 870.2800Medical magnetic tape recorder.
§ 870.2810Paper chart recorder.
§ 870.2840Apex cardiographic transducer.
§ 870.2850Extravascular blood pressure transducer.
§ 870.2855Implantable Intra-aneurysm Pressure Measurement System.
§ 870.2860Heart sound transducer.
§ 870.2870Catheter tip pressure transducer.
§ 870.2880Ultrasonic transducer.
§ 870.2890Vessel occlusion transducer.
§ 870.2900Patient transducer and electrode cable (including connector).
§ 870.2910Radiofrequency physiological signal transmitter and receiver.
§ 870.2920Telephone electrocardiograph transmitter and receiver.
eCFR Content