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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K083147
Device Name DISCOVERY MR450
Original Applicant
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha,  WI  53188
Original Contact yuan ma
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/24/2008
Decision Date 11/04/2008
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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