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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K113074
Device Name CMAP PRO
Applicant
MEDICAL TECHNOLOGIES, INC.
5901-J WYOMING NE,
SUITE 125
ALBUQUERQUE,  NM  87106
Applicant Contact ANGELA MORRIS
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number890.1375
Classification Product Code
IKN  
Date Received10/17/2011
Decision Date 02/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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