FDA 510(k)

Armis VeriCyn 상처 씻기

K-번호: K220759 · 2023-05-25

결정일2023-05-25

제품 코드FQH

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Armis VeriCyn Wound Wash is the device name listed in this FDA 510(k) record. The listed applicant is Armis Biopharma, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K220759. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Armis VeriCyn Wound Wash?

Armis VeriCyn Wound Wash is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Armis Biopharma, Inc.. The 510(k) number is K220759.

When did Armis VeriCyn Wound Wash receive FDA 510(k) clearance?

Armis VeriCyn Wound Wash received FDA 510(k) clearance on 2023-05-25, under 510(k) number K220759.

Who is the listed applicant for Armis VeriCyn Wound Wash?

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

What is the FDA product code for Armis VeriCyn Wound Wash?

The FDA product code for Armis VeriCyn Wound Wash is FQH.

Armis Biopharma, Inc.를 신청인으로 등재한 기타 기록

K202777VeriFixx™ Small Bone Implant

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