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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, tomography, computed, emission
510(k) Number K192277
Device Name CardIQ Flow
Applicant
GE Medical Systems SCS
283 rue de la Miniere
buc,  FR 78530
Applicant Contact elizabeth mathew
Correspondent
GE Medical Systems SCS
283 rue de la Miniere
buc,  FR 78530
Correspondent Contact elizabeth mathew
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received08/22/2019
Decision Date 02/14/2020
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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