Code of Federal Regulations · Section
§ 870.2860 — Heart Sound Transducer
21 C.F.R. § 870.2860
View:
(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).
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351