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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 870 - Cardiovascular Devices |
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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. |