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FDA 510(k)

Biomoneta Avata Rx

K-Number: K251872 · 2025-11-14

Decision Date2025-11-14
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biomoneta Avata Rx is the device name listed in this FDA 510(k) record. The listed applicant is Biomoneta Research Private Limited. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K251872. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biomoneta Avata Rx?

Biomoneta Avata Rx is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Biomoneta Research Private Limited. The 510(k) number is K251872.

When did Biomoneta Avata Rx receive FDA 510(k) clearance?

Biomoneta Avata Rx received FDA 510(k) clearance on 2025-11-14, under 510(k) number K251872.

Who is the listed applicant for Biomoneta Avata Rx?

The FDA 510(k) record lists Biomoneta Research Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biomoneta Avata Rx?

The FDA product code for Biomoneta Avata Rx is FRF.

Related Devices (Code: FRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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