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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 K123843
Device Name NEUROEPG SYSTEM
Applicant
STROHL MEDICAL TECHNOLOGIES
8 GRAY LODGE RD
KITTERY,  ME  03904
Applicant Contact JIM GRECO
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWJ   GXY  
Date Received12/13/2012
Decision Date 06/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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