FDA 510(k)

FUJIFILM 히트 모델 DH-28GR, DH-29CR 및 DH-30CR

K-번호: K162749 · 2017-06-15

결정일2017-06-15

제품 코드FDS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K162749. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162749.

When did FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR receive FDA 510(k) clearance?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR received FDA 510(k) clearance on 2017-06-15, under 510(k) number K162749.

Who is the listed applicant for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

The FDA product code for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is FDS.

Fujifilm Medical Systems U.S.A, Inc.를 신청인으로 등재한 기타 기록

K171291FUJIFILM 브론초스코프 모델 EB-530P K171207FUJIFILM 울트라소닉 프로세서 SP-900 및 FUJIFILM 울트라소닉探头 PB2020-M K173132ASPIRE Cristalle K171463ASPIRE Bellus II K152257푸지프림 드وا덴스코프 모델 ED-530XT K163624드라이브 V시스템 II 이미지 처리 옵션을 포함한 FDX 콘솔(드라이브 V시스템 ID300CL 및 드라이브 V시스템 ID600)

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