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510(k) K251872

Biomoneta Avata Rx by Biomoneta Research Private Limited — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2025
Date Received
June 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

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