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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 K033475
Device Name WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Applicant Contact SERRAH NAMINI
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Correspondent Contact SERRAH NAMINI
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received11/03/2003
Decision Date 01/07/2004
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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