E-Shield Multi-paried Subdermal Needle Electrodes— 510(k) K142470

Name: FDA 510(k) clearance K142470
Creator: U.S. Food and Drug Administration
Published: 2014-11-05

Substantially Equivalent

Neuroinvent, Inc.

FDA 510(k) clearance K142470 for E-Shield Multi-paried Subdermal Needle Electrodes, Substantially Equivalent on 2014-11-05. Applicant: Neuroinvent, Inc.. Device class: 2.

Clearance details

Applicant: Neuroinvent, Inc.
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2014-09-03
Decision date: 2014-11-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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