FDA 510(k)

PENTAX Video Upper G.I. Scope EG34-i10

Número K: K180292 · 2018-10-12

RequerentePentax Medical of America, Inc.

Data da decisão2018-10-12

Código do produtoFDS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PENTAX Video Upper G.I. Scope EG34-i10 is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical of America, Inc.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K180292. 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 PENTAX Video Upper G.I. Scope EG34-i10?

PENTAX Video Upper G.I. Scope EG34-i10 is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Pentax Medical of America, Inc.. The 510(k) number is K180292.

When did PENTAX Video Upper G.I. Scope EG34-i10 receive FDA 510(k) clearance?

PENTAX Video Upper G.I. Scope EG34-i10 received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180292.

Who is the listed applicant for PENTAX Video Upper G.I. Scope EG34-i10?

The FDA 510(k) record lists Pentax Medical of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Video Upper G.I. Scope EG34-i10?

The FDA product code for PENTAX Video Upper G.I. Scope EG34-i10 is FDS.

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Fonte oficial

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