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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K841612
Device Name NEUROPACK II 5100
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Regulation Number882.1835
Classification Product Code
GWL  
Date Received04/10/1984
Decision Date 06/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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