FDA 510(k)

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

K-번호: K253033 · 2025-10-21

결정일2025-10-21

제품 코드ONB

자문 위원회HO

결정Substantially Equivalent

기기 요약

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor 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 2025-10-21 under 510(k) number K253033. 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 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K253033.

When did Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor receive FDA 510(k) clearance?

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor received FDA 510(k) clearance on 2025-10-21, under 510(k) number K253033.

Who is the listed applicant for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

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 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

The FDA product code for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is ONB.

Simplivia Healthcare , Ltd.를 신청인으로 등재한 기타 기록

K251411Chemfort Female Luer Lock Adaptor K231286Chemfort® Catheter Adaptor K210707OnGuard2 Chemfort Closed Administration (CADM)K201142TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set K192866Chemfort CSTD

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