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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 K071985
Device Name GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
Applicant
General Electric Co.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact ALLEN SCHUH
Correspondent
General Electric Co.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact ALLEN SCHUH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/19/2007
Decision Date 08/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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