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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K843808
Device Name DUAL CHENNEL BRAIN ACTIVITY MONITOR
Applicant
Datex Division Instrumentarium Corp.
P.O. Box 357
Sf-00101
Helsinki 10 Finland, 
Applicant Contact OLLI RIIKKALA
Correspondent
Datex Division Instrumentarium Corp.
P.O. Box 357
Sf-00101
Helsinki 10 Finland, 
Correspondent Contact OLLI RIIKKALA
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
Date Received09/27/1984
Decision Date 11/08/1984
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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