FDA 510(k)

아쿠아A

K-번호: K213507 · 2022-07-27

신청자Fresenius Medical Care Rental Therapies Group, LLC

결정일2022-07-27

제품 코드FIP

자문 위원회GU

결정Substantially Equivalent

기기 요약

AquaA is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Rental Therapies Group, LLC. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K213507. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AquaA?

AquaA is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Fresenius Medical Care Rental Therapies Group, LLC. The 510(k) number is K213507.

When did AquaA receive FDA 510(k) clearance?

AquaA received FDA 510(k) clearance on 2022-07-27, under 510(k) number K213507.

Who is the listed applicant for AquaA?

The FDA 510(k) record lists Fresenius Medical Care Rental Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaA?

The FDA product code for AquaA is FIP.

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아쿠아A

기기 요약

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관련 임상시험

관련 기기 (코드: FIP)

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