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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 K103649
Device Name VOLUSON S6, VOLUSON S8
Applicant
GE Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/15/2010
Decision Date 03/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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