Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Abnormal Breath Sound Device

FDA product code PHZ · 7 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.1900
Review panel
AN
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2021-03-11 – 2026-09-25

The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.

↑