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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 K111445
Device Name DISCOVERY NM 630
Original Applicant
GE HEALTHCARE
4 hayozma street
tirat hacarmel,  IS 30200
Original Contact tal bresler-stramer
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/24/2011
Decision Date 06/03/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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