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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K190334
Device Name MIMOSA Imager
Applicant
MIMOSA Diagnostics Inc
1 Yonge St Suite 201
Toronto,  CA M5E1E5
Applicant Contact Yuan Fang
Correspondent
MIMOSA Diagnostics Inc
1 Yonge St Suite 201
Toronto,  CA M5E1E5
Correspondent Contact Yuan Fang
Regulation Number870.2700
Classification Product Code
MUD  
Date Received02/14/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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