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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 K870815
Device Name KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265
Applicant
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Applicant Contact ELLEN F BENEDICT
Correspondent
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Correspondent Contact ELLEN F BENEDICT
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received03/03/1987
Decision Date 02/01/1988
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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