21 CFR § 870.2860 Cardiovascular Devices

§ 870.2860 Heart sound transducer.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.2855 Implantable Intra-aneurysm Pressure Measurement System.§ 870.2870 Catheter tip pressure transducer. →