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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K992742
Device Name NEUROFAX, MODEL EEG-1100A
Applicant
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612
Applicant Contact BONNIE BISHOP
Correspondent
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612
Correspondent Contact BONNIE BISHOP
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received08/16/1999
Decision Date 10/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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