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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K251872
Device Name Biomoneta Avata Rx
Applicant
Biomoneta Research Private Limited
1st Floor, 1401, Railway Parallel Rd., A Block,
Sahakara Nagar, Bengaluru (Bangalore) Urban
Bengaluru,  IN 560092
Applicant Contact Arindam Ghatak
Correspondent
I3cglobal Reghelps Pvt, Ltd.
Mr-02, D-4, First Floor, Clayworks Shankaraa, H&G
Shankaraa, Doddakallasandra
Bengaluru,  IN 560062
Correspondent Contact Amrutha Rai
Regulation Number880.5045
Classification Product Code
FRF  
Date Received06/18/2025
Decision Date 11/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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