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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 K080515
Device Name FMRI HARDWARE SYSTEM
Applicant
Nordicneurolab
Mollendalsveien 65c
Bergen,  NO N-5009
Applicant Contact STIAN SCISLY SAGEVIK
Correspondent
Nordicneurolab
Mollendalsveien 65c
Bergen,  NO N-5009
Correspondent Contact STIAN SCISLY SAGEVIK
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/25/2008
Decision Date 05/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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