FDA 510(k)

하이드로벤 12, 하이드로벤 12 의복

K-번호: K152228 · 2016-04-04

결정일2016-04-04

제품 코드JOW

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

Hydroven 12, Hydroven 12 Garments is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K152228. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Hydroven 12, Hydroven 12 Garments?

Hydroven 12, Hydroven 12 Garments is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K152228.

When did Hydroven 12, Hydroven 12 Garments receive FDA 510(k) clearance?

Hydroven 12, Hydroven 12 Garments received FDA 510(k) clearance on 2016-04-04, under 510(k) number K152228.

Who is the listed applicant for Hydroven 12, Hydroven 12 Garments?

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

What is the FDA product code for Hydroven 12, Hydroven 12 Garments?

The FDA product code for Hydroven 12, Hydroven 12 Garments is JOW.

Huntleigh Healthcare , Ltd.를 신청인으로 등재한 기타 기록

K250777Sonicaid Team3 K241368Sonicaid Team3 K211200WoundExpress K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes

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