FDA 510(k)

Proxima

K-Number: K220591 · 2022-12-15

Decision Date2022-12-15

Product CodeNFB

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Proxima is the device name listed in this FDA 510(k) record. The listed applicant is Dynasthetics, LLC. It received FDA 510(k) clearance on 2022-12-15 under 510(k) 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. The listed applicant is Dynasthetics, LLC. The 510(k) number is K220591.

When did Proxima receive FDA 510(k) clearance?

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

Who is the listed applicant for Proxima?

The FDA 510(k) record lists Dynasthetics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proxima?

The FDA product code for Proxima is NFB.

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC K200401ApogeeIncoba Ltd D/B/A Dynaris K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs

Official Source

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