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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 K232680
Device Name fMRI Hardware System
Applicant
Nordicneurolab AS
Mollendalsveien 1
Bergen,  NO 5009
Applicant Contact Chandana Gurung Bhandari
Correspondent
Nordicneurolab AS
Mollendalsveien 1
Bergen,  NO 5009
Correspondent Contact Chandana Gurung Bhandari
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/01/2023
Decision Date 12/13/2023
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
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