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FDA 510(k)

Proxima

K-Number: K220591 · 2022-12-15

ApplicantDynasthetics, LLC
Decision Date2022-12-15
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Proxima is a medical device manufactured by Dynasthetics, LLC. It received FDA 510(k) clearance on 2022-12-15 under approval number K220591. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Proxima?

Proxima is a medical device that received FDA 510(k) clearance on 2022-12-15. It is manufactured by Dynasthetics, LLC. The 510(k) number is K220591.

When was Proxima approved by the FDA?

Proxima received FDA 510(k) clearance on 2022-12-15, under approval number K220591.

What company makes Proxima?

Proxima is manufactured by Dynasthetics, LLC.

What is the FDA product code for Proxima?

The FDA product code for Proxima is NFB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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