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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 K071899
Device Name BIS MODULE FOR ENVOY PATIENT MONITOR
Applicant
Mennen Medical , Ltd.
4 Hayarden St., Yavne
P.O. Box 102
Rohovot,  IL 76100
Applicant Contact IFAT OREN
Correspondent
Mennen Medical , Ltd.
4 Hayarden St., Yavne
P.O. Box 102
Rohovot,  IL 76100
Correspondent Contact IFAT OREN
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
MHX   OLT   OMC   ORT  
Date Received07/09/2007
Decision Date 10/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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