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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K162571
Device Name Bioflux Software
Applicant
Biotricity, Inc.
75 International Blvd., Suite 300
Toronto,  CA M9W 6L9
Applicant Contact Tom Elias
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2800
Classification Product Code
DSH  
Date Received09/15/2016
Decision Date 10/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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