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FDA PRODUCT CODE · CLASS II

OCR — Lung Sound Monitor

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

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1875
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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