21 CFR § 870.2860 - Heart sound transducer.

§ 870.2860 Heart sound transducer.

(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).