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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 K113350
Device Name BRIVO NM 615
Applicant
GE HEALTHCARE
4 HAYOZMA STREET
tirat hacarmel,  IL 30200
Applicant Contact eli werner
Correspondent
GE HEALTHCARE
4 HAYOZMA STREET
tirat hacarmel,  IL 30200
Correspondent Contact eli werner
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received11/14/2011
Decision Date 12/05/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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