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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplitude-Integrated Electroencephalograph
510(k) Number K791580
Device Name CEREBRAL FUNCTION MONITOR 870
Applicant
Applied Medical Research
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Applied Medical Research
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Code
OMC  
Date Received08/17/1979
Decision Date 09/04/1979
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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