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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K082614
Device Name EVOX ELECTRO DIAGNOSTIC DEVICE
Applicant
LABORIE MEDICAL TECHNOLOGIES, INC.
400 AVENUE D SUITE 10
WILLISTON,  VT  05495
Applicant Contact BARBARA MORNET
Correspondent
LABORIE MEDICAL TECHNOLOGIES, INC.
400 AVENUE D SUITE 10
WILLISTON,  VT  05495
Correspondent Contact BARBARA MORNET
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Code
JXE  
Date Received09/09/2008
Decision Date 03/06/2009
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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