FDA 510(k)

푸지프림 울트라사운드 프로세서 SU-1 플래티넘 및 SU-1

K-번호: K153206 · 2016-03-03

결정일2016-03-03

제품 코드FDS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K153206. 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 Ultrasonic Processors SU-1 PLATINUM and SU-1?

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K153206.

When did Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 receive FDA 510(k) clearance?

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 received FDA 510(k) clearance on 2016-03-03, under 510(k) number K153206.

Who is the listed applicant for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1?

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

What is the FDA product code for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1?

The FDA product code for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is FDS.

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

K163675Processor VP-7000, Light Source BL-7000 K151474푸지프림 디아테르미크 슬라이터 (플러시칼버), 디아테르미크 슬라이터 (클러치컷터)

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