Name: Predicase
Price: 199 USD

K-number	K251872
Device name	Biomoneta Avata Rx
Applicant	Biomoneta Research Private Limited
Product code	FRF
Device class	Class II
Decision date	Nov 14, 2025
Decision	Substantially Equivalent
Regulation	880.5045

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Biomoneta Avata Rx

Everything you need for a 510(k) submission. Nothing you don't.