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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K854663
Device Name NEUROFAX 7310 SERIES (EEG)
Applicant
NIHON KOHDEN AMERICA, INC.
17112 ARMSTRONG AVE.
IRVINE,  CA  92714
Applicant Contact DIANA BEAL
Correspondent
NIHON KOHDEN AMERICA, INC.
17112 ARMSTRONG AVE.
IRVINE,  CA  92714
Correspondent Contact DIANA BEAL
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received11/20/1985
Decision Date 08/20/1986
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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