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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle, Diagnostic Electromyograph
510(k) Number K143433
Device Name Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
Applicant
Natus Manufacturing Limited
IDA Business Park
Gort,  IE
Applicant Contact Michael Galvin
Correspondent
Natus Manufacturing Limited
IDA Business Park
Gort,  IE
Correspondent Contact Michael Galvin
Regulation Number890.1385
Classification Product Code
IKT  
Date Received12/01/2014
Decision Date 08/28/2015
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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