FDA 510(k)

EPX-4440FN Digital Video Processor with Light Source

Número K: K180414 · 2018-05-24

RequerenteFujifilm New Development U.S.A., Inc.

Data da decisão2018-05-24

Código do produtoFET

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

EPX-4440FN Digital Video Processor with Light Source is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm New Development U.S.A., Inc.. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K180414. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EPX-4440FN Digital Video Processor with Light Source?

EPX-4440FN Digital Video Processor with Light Source is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Fujifilm New Development U.S.A., Inc.. The 510(k) number is K180414.

When did EPX-4440FN Digital Video Processor with Light Source receive FDA 510(k) clearance?

EPX-4440FN Digital Video Processor with Light Source received FDA 510(k) clearance on 2018-05-24, under 510(k) number K180414.

Who is the listed applicant for EPX-4440FN Digital Video Processor with Light Source?

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

What is the FDA product code for EPX-4440FN Digital Video Processor with Light Source?

The FDA product code for EPX-4440FN Digital Video Processor with Light Source is FET.

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