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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 K113507
Device Name KENT CAMERA
Applicant
Kent Imaging, Inc.
1440, 720- 13th Ave. SW
Calgary,  CA T2R 1M5
Applicant Contact DARRELL BARNHART
Correspondent
Kent Imaging, Inc.
1440, 720- 13th Ave. SW
Calgary,  CA T2R 1M5
Correspondent Contact DARRELL BARNHART
Regulation Number870.2700
Classification Product Code
MUD  
Date Received11/28/2011
Decision Date 08/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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