FDA 510(k)

FemDx FalloView

Número K: K221965 · 2023-03-17

Data da decisão2023-03-17

Código do produtoMKO

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

FemDx FalloView is the device name listed in this FDA 510(k) record. The listed applicant is Femdx Medsystems, Inc.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K221965. The device is classified under product code MKO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FemDx FalloView?

FemDx FalloView is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Femdx Medsystems, Inc.. The 510(k) number is K221965.

When did FemDx FalloView receive FDA 510(k) clearance?

FemDx FalloView received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221965.

Who is the listed applicant for FemDx FalloView?

The FDA 510(k) record lists Femdx Medsystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FemDx FalloView?

The FDA product code for FemDx FalloView is MKO.

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