510(k) K251872

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

K251872 is an FDA 510(k) premarket notification submitted by Biomoneta Research Private Limited for the device "Biomoneta Avata Rx". The FDA issued a decision of Substantially Equivalent on November 14, 2025. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.