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FDA 510(k) Application Details - K190334
Device Classification Name
Oximeter, Tissue Saturation
More FDA Info for this Device
510(K) Number
K190334
Device Name
Oximeter, Tissue Saturation
Applicant
MIMOSA Diagnostics Inc
1 Yonge St Suite 201
Toronto M5E1E5 CA
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Contact
Yuan Fang
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
MUD
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More FDA Info for this Product Code
Date Received
02/14/2019
Decision Date
11/01/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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