21 C.F.R. § 870.2860
Heart sound transducer.
Cite as 21 C.F.R. § 870.2860 (2026)
(a) Identification. A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds. (b) Classification. Class II (performance standards).