§ 870.2390. Phonocardiograph.
91 words·~1 min read·
/us/cfr/t21/s§ 870.2390·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]