21 C.F.R. · Food and Drugs
21 C.F.R. § 870.2390

Phonocardiograph.

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21 C.F.R. § 870.2390 — Phonocardiograph.

§ 870.2390 Phonocardiograph. (a) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart sounds. (b) 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. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

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The regulatory text of 21 C.F.R. § 870.2390 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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