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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 K092079
Device Name MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
Applicant
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact JAMES T TURNER
Correspondent
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact JAMES T TURNER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/09/2009
Decision Date 08/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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