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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evoked Potential Stimulator, Thermal
510(k) Number K041908
Device Name CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
Applicant
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
4050 OLSON MEMORIAL HIGHWAY
SUITE 350
MINNEAPOLIS,  MN  55422
Applicant Contact TRACY GRAY
Correspondent
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
4050 OLSON MEMORIAL HIGHWAY
SUITE 350
MINNEAPOLIS,  MN  55422
Correspondent Contact TRACY GRAY
Regulation Number882.1870
Classification Product Code
NTU  
Date Received07/15/2004
Decision Date 02/25/2005
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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