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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K010590
Device Name NEUROPACK MICRO, MODEL MED-9100A SERIES
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Applicant Contact BONNIE BISHOP
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent Contact BONNIE BISHOP
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
GWE   GWF   GWJ   GWQ   GZO  
JXE  
Date Received02/27/2001
Decision Date 06/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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