FDA 510(k)

OnGuard2 Chemfort Closed Administration (CADM)

K-번호: K210707 · 2021-09-23

결정일2021-09-23

제품 코드ONB

자문 위원회HO

결정Substantially Equivalent

기기 요약

OnGuard2 Chemfort Closed Administration (CADM) is the device name listed in this FDA 510(k) record. The listed applicant is Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K210707. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the OnGuard2 Chemfort Closed Administration (CADM)?

OnGuard2 Chemfort Closed Administration (CADM) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K210707.

When did OnGuard2 Chemfort Closed Administration (CADM) receive FDA 510(k) clearance?

OnGuard2 Chemfort Closed Administration (CADM) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K210707.

Who is the listed applicant for OnGuard2 Chemfort Closed Administration (CADM)?

The FDA 510(k) record lists Simplivia Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OnGuard2 Chemfort Closed Administration (CADM)?

The FDA product code for OnGuard2 Chemfort Closed Administration (CADM) is ONB.

Simplivia Healthcare , Ltd.를 신청인으로 등재한 기타 기록

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