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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K120221
Device Name GE ECHOPAC
Original Applicant
GE HEALTHCARE
9900 w. innovation drive
rp-2138
wauwatosa,  WI  53226
Original Contact bryan behn
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/25/2012
Decision Date 03/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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