Cleared Traditional

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

K143433 · Natus Manufacturing Limited · Neurology
Aug 2015
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K143433 is an FDA 510(k) clearance for the 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, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Natus Manufacturing Limited (Gort, IE). The FDA issued a Cleared decision on August 28, 2015, 270 days after receiving the submission on December 1, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K143433 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2014
Decision Date August 28, 2015
Days to Decision 270 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IKT — Electrode, Needle, Diagnostic Electromyograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1385

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