FDA 510(k)

ENDOCAM Flex HD Camera System 5521

Número K: K161204 · 2017-01-11

RequerenteRichard Wolf Medical Instruments Corporation

Data da decisão2017-01-11

Código do produtoFET

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENDOCAM Flex HD Camera System 5521 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K161204. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ENDOCAM Flex HD Camera System 5521?

ENDOCAM Flex HD Camera System 5521 is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K161204.

When did ENDOCAM Flex HD Camera System 5521 receive FDA 510(k) clearance?

ENDOCAM Flex HD Camera System 5521 received FDA 510(k) clearance on 2017-01-11, under 510(k) number K161204.

Who is the listed applicant for ENDOCAM Flex HD Camera System 5521?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCAM Flex HD Camera System 5521?

The FDA product code for ENDOCAM Flex HD Camera System 5521 is FET.

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