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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 K150087
Device Name Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
Applicant
GE VINGMED ULTRASOUND AS
HORTEN,  NO 3191
Applicant Contact BRYAN BEHN
Correspondent
GE Healthcare
9900 W Innovation Dr., RP-2138
Wauwatosa,  WI  53226
Correspondent Contact Bryan Behn
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/15/2015
Decision Date 03/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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