FDA 510(k)

Chemfort® 캐터터 어댑터

K-번호: K231286 · 2023-08-02

결정일2023-08-02

제품 코드ONB

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

결정Substantially Equivalent

기기 요약

Chemfort® Catheter Adaptor 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 2023-08-02 under 510(k) number K231286. 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® Catheter Adaptor?

Chemfort® Catheter Adaptor is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K231286.

When did Chemfort® Catheter Adaptor receive FDA 510(k) clearance?

Chemfort® Catheter Adaptor received FDA 510(k) clearance on 2023-08-02, under 510(k) number K231286.

Who is the listed applicant for Chemfort® Catheter Adaptor?

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® Catheter Adaptor?

The FDA product code for Chemfort® Catheter Adaptor is ONB.

Simplivia Healthcare , Ltd.를 신청인으로 등재한 기타 기록

K253033Chemfort® 28일 20mm 액체 병 어댑터 및 13mm 변환기 K251411케미포트 여성 루어 락 어댑터 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 K192866케미포트 CSTD

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