• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-