FDA 510(k)

Sistema AquaShield CO2- Fujifilm

Número K: K173650 · 2018-01-05

RequerenteUnited States Endoscopy Group, Inc.

Data da decisão2018-01-05

Código do produtoFEQ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AquaShield System CO2- Fujifilm is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K173650. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AquaShield System CO2- Fujifilm?

AquaShield System CO2- Fujifilm is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K173650.

When did AquaShield System CO2- Fujifilm receive FDA 510(k) clearance?

AquaShield System CO2- Fujifilm received FDA 510(k) clearance on 2018-01-05, under 510(k) number K173650.

Who is the listed applicant for AquaShield System CO2- Fujifilm?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaShield System CO2- Fujifilm?

The FDA product code for AquaShield System CO2- Fujifilm is FEQ.

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Fonte oficial

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