OCR

Lung Sound Monitor

Product code

OCR

Device name

Lung Sound Monitor

Device class

Class 2

21 CFR

21 CFR 870.1875

Medical specialty

Cardiovascular

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

The lung sound monitor is intended for use in monitoring and recording lung sounds.

Definition text from the FDA device classification database (U.S. federal government work, public domain).