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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 K201976
Device Name SnapshotNIR
Applicant
Kent Imaging
804b 16th Ave. SW
Calgary,  CA t2r 0s9
Applicant Contact Liz Newell
Correspondent
Kent Imaging
804b 16th Ave. SW
Calgary,  CA t2r 0s9
Correspondent Contact Liz Newell
Regulation Number870.2700
Classification Product Code
MUD  
Date Received07/16/2020
Decision Date 11/10/2020
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
Recalls CDRH Recalls
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