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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 K024316
Device Name NIM-PRS
Applicant
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact MARTIN SARGENT
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number890.1375
Classification Product Code
IKN  
Date Received12/26/2002
Decision Date 01/06/2003
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
Predetermined Change
Control Plan Authorized		 No
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