DEVICE CLASS
Class II
REGULATION
21 CFR 880.5400
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES
Recent clearances
K251619Drägerwerk AG & Co. KGaA · 510k2026-02-13
K251663Datex-Ohmeda, Inc. · 510k2025-10-22
K243437Mom Incubators Limited · 510k2025-08-14
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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