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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 K240601
Device Name SnapshotNIR model KD205
Applicant
Kent Imaging, Inc.
Suite 300, 1210 8 St. SW
Calgary,  CA T2R 1L3
Applicant Contact Hitalo Arume
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number870.2700
Classification Product Code
MUD  
Date Received03/04/2024
Decision Date 04/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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