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FDA 510(k)

MIMOSA Imager

K-Number: K190334 · 2019-11-01

ApplicantMimosa Diagnostics, Inc.
Decision Date2019-11-01
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MIMOSA Imager is a medical device manufactured by Mimosa Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-01 under approval number K190334. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIMOSA Imager?

MIMOSA Imager is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Mimosa Diagnostics, Inc.. The 510(k) number is K190334.

When was MIMOSA Imager approved by the FDA?

MIMOSA Imager received FDA 510(k) clearance on 2019-11-01, under approval number K190334.

What company makes MIMOSA Imager?

MIMOSA Imager is manufactured by Mimosa Diagnostics, Inc..

What is the FDA product code for MIMOSA Imager?

The FDA product code for MIMOSA Imager is MUD.

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Official Source

View on FDA Database →

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

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