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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 K072952
Device Name GE ECHOPAC
Original Applicant
GENERAL ELECTRIC CO.
9900 innovation drive
wauwatosa,  WI  53226
Original Contact allen schuh
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/18/2007
Decision Date 11/16/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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