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Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES / PART 870 - CARDIOVASCULAR DEVICES / Subpart B - Cardiovascular Diagnostic Devices / § 870.1875 Stethoscope.
§ 870.1875 Stethoscope.

(a) Manual stethoscope - (1) Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

(b) Electronic stethoscope - (1) Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001; 84 FR 71811, Dec. 30, 2019]
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