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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K001692
Device Name NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
Applicant
Neurosoft, Inc.
5700 Cromo, Suite 100
El Paso,  TX  79912
Applicant Contact DAVID B JONES
Correspondent
Neurosoft, Inc.
5700 Cromo, Suite 100
El Paso,  TX  79912
Correspondent Contact DAVID B JONES
Regulation Number882.1550
Classification Product Code
JXE  
Subsequent Product Codes
GWE   GWF   GWJ   IKN  
Date Received06/02/2000
Decision Date 11/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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