FDA 510(k)

Fujifilm Duodenoscope Model ED-530XT

K-번호: K152257 · 2017-07-21

결정일2017-07-21

제품 코드FDT

자문 위원회GU

결정Substantially Equivalent

기기 요약

Fujifilm Duodenoscope Model ED-530XT 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 2017-07-21 under 510(k) number K152257. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Fujifilm Duodenoscope Model ED-530XT?

Fujifilm Duodenoscope Model ED-530XT is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K152257.

When did Fujifilm Duodenoscope Model ED-530XT receive FDA 510(k) clearance?

Fujifilm Duodenoscope Model ED-530XT received FDA 510(k) clearance on 2017-07-21, under 510(k) number K152257.

Who is the listed applicant for Fujifilm Duodenoscope Model ED-530XT?

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 Duodenoscope Model ED-530XT?

The FDA product code for Fujifilm Duodenoscope Model ED-530XT is FDT.

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

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