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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K073153
Device Name CARDIQ FUNCTION XPRESS
Applicant
GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE BP 34
buc cedex,  FR 78533
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
twinsburg,  OH  44087
Correspondent Contact jay y kogoma
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received11/08/2007
Decision Date 02/26/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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