← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
PHZ — Abnormal Breath Sound Device
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
DEVICE CLASS
Class II
REGULATION
21 CFR 868.1900
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K252844Tyto Care , Ltd. · 510k2026-06-02
K243567Tyto Care , Ltd. · 510k2025-04-07
Related on SPEQ
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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