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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
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
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
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