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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
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