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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 K863124
Device Name MODEL 8 EEG PREAMPLIFIER
Applicant
Micro Tronics Corp.
P.O. Box 399
Carrboro,  NC  27510
Applicant Contact KARLA SMITH
Correspondent
Micro Tronics Corp.
P.O. Box 399
Carrboro,  NC  27510
Correspondent Contact KARLA SMITH
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received08/14/1986
Decision Date 11/18/1986
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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