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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K173810
Device Name Ventripoint Medical System Plus (VMS+)
Applicant
Ventripoint Diagnostics, Ltd.
2 Sheppard Avenue East, Suite 605
Toronto,  CA M2N 5Y7
Applicant Contact Desmond Hirson
Correspondent
Ventripoint Diagnostics, Ltd.
2 Sheppard Avenue East, Suite 605
Toronto,  CA M2N 5Y7
Correspondent Contact Desmond Hirson
Regulation Number892.1550
Classification Product Code
IYN  
Date Received12/15/2017
Decision Date 05/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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