FDA 510(k)

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

Número K: K162749 · 2017-06-15

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2017-06-15

Código do produtoFDS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR 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 2017-06-15 under 510(k) number K162749. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162749.

When did FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR receive FDA 510(k) clearance?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR received FDA 510(k) clearance on 2017-06-15, under 510(k) number K162749.

Who is the listed applicant for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

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 Hood Models DH-28GR, DH-29CR and DH-30CR?

The FDA product code for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is FDS.

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Fonte oficial

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