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FDA 510(k)

FemDx FalloView

K-Number: K221965 · 2023-03-17

ApplicantFemdx Medsystems, Inc.
Decision Date2023-03-17
Product CodeMKO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the FemDx FalloView?

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

When was FemDx FalloView approved by the FDA?

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

What company makes FemDx FalloView?

FemDx FalloView is manufactured by Femdx Medsystems, Inc..

What is the FDA product code for FemDx FalloView?

The FDA product code for FemDx FalloView is MKO.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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