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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 K031995
Device Name COMPREHENSIVE NEUROMUSCULAR PROFILER
Applicant
Medical Technologies Unlimited, Inc.
7538 Bear Canyon Rd. NE
Albuquerque,  NM  87109
Applicant Contact ANGELA MORRIS
Correspondent
Medical Technologies Unlimited, Inc.
7538 Bear Canyon Rd. NE
Albuquerque,  NM  87109
Correspondent Contact ANGELA MORRIS
Regulation Number890.1375
Classification Product Code
IKN  
Date Received06/27/2003
Decision Date 01/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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