← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

FRF — Cleaner, Air, Medical Recirculating

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5045
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K251872Biomoneta Research Private Limited · 510k2025-11-14
K242102Cerrozone, LLC · 510k2024-11-19

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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