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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 K942604
Device Name SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
Applicant
GE MEDICAL SYSTEMS
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER, PH.D.
Correspondent
GE MEDICAL SYSTEMS
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact LARRY A KROGER, PH.D.
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/01/1994
Decision Date 11/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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