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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 echo, ultrasonic
510(k) Number K120201
Device Name GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Applicant
GE VINGMED ULTRASOUND AS
9900 W INNOVATION DR., RP-2138
WAUWATOSA,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE VINGMED ULTRASOUND AS
9900 W INNOVATION DR., RP-2138
WAUWATOSA,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received01/23/2012
Decision Date 04/19/2012
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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