FDA 510(k)

FUJIFILM Bronchoscope Model EB-530P

Número K: K171291 · 2018-01-19

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2018-01-19

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

FUJIFILM Bronchoscope Model EB-530P 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 2018-01-19 under 510(k) number K171291. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FUJIFILM Bronchoscope Model EB-530P?

FUJIFILM Bronchoscope Model EB-530P is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171291.

When did FUJIFILM Bronchoscope Model EB-530P receive FDA 510(k) clearance?

FUJIFILM Bronchoscope Model EB-530P received FDA 510(k) clearance on 2018-01-19, under 510(k) number K171291.

Who is the listed applicant for FUJIFILM Bronchoscope Model EB-530P?

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 Bronchoscope Model EB-530P?

The FDA product code for FUJIFILM Bronchoscope Model EB-530P is EOQ.

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Fonte oficial

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