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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conditioner, Signal, Physiological
510(k) Number K905594
Device Name NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
Applicant
NIHON KOHDEN AMERICA, INC.
17112 ARMSTRONG AVE.
IRVINE,  CA  92714
Applicant Contact BILL ABRAMS
Correspondent
NIHON KOHDEN AMERICA, INC.
17112 ARMSTRONG AVE.
IRVINE,  CA  92714
Correspondent Contact BILL ABRAMS
Regulation Number882.1845
Classification Product Code
GWK  
Date Received12/13/1990
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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