← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
SGR — Noninvasive Positive Airway Pressure System, Facility Use
To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.
DEVICE CLASS
Class II
REGULATION
21 CFR 868.5895
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
K251165Innaccel Technologies Private Limited · 510k2026-01-06
K250651Fisher & Paykel Healthcare, Ltd. · 510k2025-11-19
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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