21 CFR 870.2860 — Transducer, Heart Sound

Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2860

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JOOTransducer, Heart Sound203rd Party
Innolitics

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