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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,  IL 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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