FDA 510(k)

Reprocesses Umbilical Cable

K-번호: K221854 · 2022-08-06

결정일2022-08-06

제품 코드NLH

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정Substantially Equivalent

기기 요약

Reprocesses Umbilical Cable is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2022-08-06 under 510(k) number K221854. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Reprocesses Umbilical Cable?

Reprocesses Umbilical Cable is a medical device that received FDA 510(k) clearance on 2022-08-06. The listed applicant is Innovative Health, LLC. The 510(k) number is K221854.

When did Reprocesses Umbilical Cable receive FDA 510(k) clearance?

Reprocesses Umbilical Cable received FDA 510(k) clearance on 2022-08-06, under 510(k) number K221854.

Who is the listed applicant for Reprocesses Umbilical Cable?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocesses Umbilical Cable?

The FDA product code for Reprocesses Umbilical Cable is NLH.

Innovative Health, LLC를 신청인으로 등재한 기타 기록

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