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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 K120888
Device Name PSG-1100 SLEEP DIAGNOSTIC SYSTEM
Applicant
Nihon Kohden Corp.
90 Icon St.
Foothill,  CA  92610
Applicant Contact STEVE GEERDES
Correspondent
Nihon Kohden Corp.
90 Icon St.
Foothill,  CA  92610
Correspondent Contact STEVE GEERDES
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLV  
Date Received03/23/2012
Decision Date 11/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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