Myoject Luer Lock Needle Electrode— 510(k) K161430

Name: FDA 510(k) clearance K161430
Creator: U.S. Food and Drug Administration
Published: 2017-03-02

Substantially Equivalent

Natus Manufacturing Limited

FDA 510(k) clearance K161430 for Myoject Luer Lock Needle Electrode, Substantially Equivalent on 2017-03-02. Applicant: Natus Manufacturing Limited. Device class: 2.

Clearance details

Applicant: Natus Manufacturing Limited
Product code: Code IKT
Device class: Class 2
Regulation: 21 CFR 890.1385
Advisory panel: Physical Medicine
Date received: 2016-05-23
Decision date: 2017-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gort, IE

Download summary PDF View on FDA.gov ↗

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