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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 K121063
Device Name VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
GE MEDICAL SYSTEM ISRAEL LTD.
9900 INNOVATION DR
WAUWATOSA,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE MEDICAL SYSTEM ISRAEL LTD.
9900 INNOVATION DR
WAUWATOSA,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ  
Date Received04/06/2012
Decision Date 08/21/2012
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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