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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 K003947
Device Name FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
Applicant
GE MEDICAL SYSTEMS
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
GE MEDICAL SYSTEMS
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/21/2000
Decision Date 03/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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