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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 K122387
Device Name VOLUSON P6, VOLUSON P8
Applicant
GE HEALTHCARE
9900 innovation drive
wauwatosa,  WI  53226
Contact bryan behn
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/06/2012
Decision Date 09/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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