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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 a medical device manufactured by Genesis Air, Inc.. It received FDA 510(k) clearance on 2023-06-02 under approval 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. It is manufactured by Genesis Air, Inc.. The 510(k) number is K222702.

When was RGS; RGS Mini approved by the FDA?

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

What company makes RGS; RGS Mini?

RGS; RGS Mini is manufactured by Genesis Air, Inc..

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

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

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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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