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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 K894608
Device Name MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM
Applicant
MICRO-SHEV LTD.
P.O. BOX 1026
EFRAT,  IL 90962
Applicant Contact ALAN SCHWEBEL
Correspondent
MICRO-SHEV LTD.
P.O. BOX 1026
EFRAT,  IL 90962
Correspondent Contact ALAN SCHWEBEL
Regulation Number882.1870
Classification Product Code
GWF  
Date Received07/18/1989
Decision Date 12/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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