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FRF

Cleaner, Air, Medical Recirculating

Product code
FRF
Device name
Cleaner, Air, Medical Recirculating
Device class
Class 2
21 CFR
21 CFR 880.5045
Medical specialty
General Hospital
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
4
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
53 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2025-11-14.

NumberDecision dateApplicantDevice nameSummary
K2518722025-11-14Biomoneta Research Private LimitedBiomoneta Avata Rx—
K2421022024-11-19Cerrozone, LLCCerroZone MiniPDF
K2406962024-06-14Suzhou Beiang Smart Technology Co., Lt…Airdog X8 Air Purifier (KJ800F-X8)FDA
K2238352023-09-18Medify Air, LLCMA-40, MA-112—

1 summaries are archived here for direct download.

Official FDA classification page: FRF
Classification and pathway per current FDA publications. Data from openFDA (CC0).