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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 K150628
Device Name VentriPoint Medical System
Applicant
Ventripoint, Inc.
1805 136th Pi NE, Suite 101
Bellevue,  WA  98005
Applicant Contact JIM BODTKE
Correspondent
Ventripoint, Inc.
1805 136th Pi NE, Suite 101
Bellevue,  WA  98005
Correspondent Contact JIM BODTKE
Regulation Number892.1550
Classification Product Code
IYN  
Date Received03/11/2015
Decision Date 05/22/2015
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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