Home / 510(k) Clearances / K143433

510(k) K143433

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 by Natus Manufacturing Limited — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2015
Date Received
December 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

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