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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 K001562
Device Name NEURO SCAN MEDICAL SYSTEMS A4000
Applicant
Neuro Scan Labs
5700 Cromo Dr., Suite 100
El Paso,  TX  79912 -5538
Applicant Contact DAVID B JONES
Correspondent
Neuro Scan Labs
5700 Cromo Dr., Suite 100
El Paso,  TX  79912 -5538
Correspondent Contact DAVID B JONES
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Code
GWF  
Date Received05/19/2000
Decision Date 08/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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