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FDA 510(k)

RGS; RGS Mini

K-Number: K222702 · 2023-06-02

ApplicantGenesis Air, Inc.
Decision Date2023-06-02
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RGS; RGS Mini is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Air, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K222702. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RGS; RGS Mini?

RGS; RGS Mini is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Genesis Air, Inc.. The 510(k) number is K222702.

When did RGS; RGS Mini receive FDA 510(k) clearance?

RGS; RGS Mini received FDA 510(k) clearance on 2023-06-02, under 510(k) number K222702.

Who is the listed applicant for RGS; RGS Mini?

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

What is the FDA product code for RGS; RGS Mini?

The FDA product code for RGS; RGS Mini is FRA.

Related Devices (Code: FRA)

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.

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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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