FDA 510(k)

MIMOSA Imager

K-Number: K190334 · 2019-11-01

Decision Date2019-11-01

Product CodeMUD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MIMOSA Imager is the device name listed in this FDA 510(k) record. The listed applicant is Mimosa Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) 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. The listed applicant is Mimosa Diagnostics, Inc.. The 510(k) number is K190334.

When did MIMOSA Imager receive FDA 510(k) clearance?

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

Who is the listed applicant for MIMOSA Imager?

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

What is the FDA product code for MIMOSA Imager?

The FDA product code for MIMOSA Imager is MUD.

Related Devices (Code: MUD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254129Spectrum-2Neko Health AB K243324Masimo O3 Regional OximeterMasimo Corporation K250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences K241393ODI-TechOdi Medical AS K240601SnapshotNIR model KD205Kent Imaging, Inc.

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.