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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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