FDA 510(k)

안전한 혈액 수집/주입 세트( nåjul hwaŏn sŭpik/ju bijip seuteu, ŭi ŭi ŭi nåjul sŭpik/ju bijip seuteu)

K-번호: K214075 · 2022-04-12

신청자Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

결정일2022-04-12

제품 코드FMI

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

결정대체적으로 동일

기기 요약

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K214075. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)?

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K214075.

When did Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) receive FDA 510(k) clearance?

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) received FDA 510(k) clearance on 2022-04-12, under 510(k) number K214075.

Who is the listed applicant for Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)?

The FDA product code for Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) is FMI.

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.를 신청인으로 등재한 기타 기록

K234024HWJECT 자동 비활성화 주사기 K230061인슐린 주사기 K230043인슐린 펜 나이프 K223323혈액 수집 주사기 (주사기 포함/포함하지 않음)K222124정화된 히포덴트릭 주사기 및/또는針, 히포덴트릭針 K222141안전 혈액 수집 주사기 (주사기 홀더 없음)

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