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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Index-Generating Electroencephalograph Software
510(k) Number K083063
Device Name BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
Applicant
MENNEN MEDICAL LTD.
4 HAYARDEN ST., YAVNE
P.O.BOX 102
REHOVOT,  IL 76100
Applicant Contact IFAT OREN
Correspondent
MENNEN MEDICAL LTD.
4 HAYARDEN ST., YAVNE
P.O.BOX 102
REHOVOT,  IL 76100
Correspondent Contact IFAT OREN
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
DSI   OLT   OMC   ORT  
Date Received10/14/2008
Decision Date 12/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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