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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 K122327
Device Name VOLUSON E6/E8/E8EXPERT/E10
Original Applicant
GE HEALTHCARE
9900 w innovation drive
wauwatosa,  WI  53226
Original Contact bryan behn
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/01/2012
Decision Date 09/21/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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