FDA 510(k)

Fujifilm Endoscope Models EC-600HL and EC-600LS

Número K: K162622 · 2016-10-18

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2016-10-18

Código do produtoFDF

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fujifilm Endoscope Models EC-600HL and EC-600LS 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 2016-10-18 under 510(k) number K162622. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fujifilm Endoscope Models EC-600HL and EC-600LS?

Fujifilm Endoscope Models EC-600HL and EC-600LS is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162622.

When did Fujifilm Endoscope Models EC-600HL and EC-600LS receive FDA 510(k) clearance?

Fujifilm Endoscope Models EC-600HL and EC-600LS received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162622.

Who is the listed applicant for Fujifilm Endoscope Models EC-600HL and EC-600LS?

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 Endoscope Models EC-600HL and EC-600LS?

The FDA product code for Fujifilm Endoscope Models EC-600HL and EC-600LS is FDF.

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