FDA 510(k)

RGS; RGS Mini

K-번호: K222702 · 2023-06-02

결정일2023-06-02

제품 코드FRA

자문 위원회HO

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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기기 요약

자주 묻는 질문

관련 기기 (코드: FRA)

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