MIMOSA Imager

510(k)K190334CardiovascularMUD

MIMOSA Diagnostics Inc is listed for MIMOSA Imager (K190334). The FDA list gives November 1, 2019 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MUD. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190334

Official FDA database record

Date of final decision: November 1, 2019
Company on the FDA list: MIMOSA Diagnostics Inc
Lead panel: Cardiovascular
Primary product code: MUD
openFDA device name for the code: Oximeter, Tissue Saturation
Device class: 2
Regulation number: 870.2700
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary