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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 K974385
Device Name MLS ELECTROMYOGRAPHIC PREAMPLIFIER
Applicant
Motion Lab Systems, Inc.
4326 Pine Park Dr.
Baton Rouge,  LA  70809
Applicant Contact EDMUND CRAMP
Correspondent
Motion Lab Systems, Inc.
4326 Pine Park Dr.
Baton Rouge,  LA  70809
Correspondent Contact EDMUND CRAMP
Regulation Number890.1375
Classification Product Code
IKN  
Date Received11/21/1997
Decision Date 02/19/1998
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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