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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
Applicant
GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact YUAN MA
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact KACHI C ENYINNA
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/24/2008
Decision Date 11/04/2008
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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