E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES— 510(k) K140200

Name: FDA 510(k) clearance K140200
Creator: U.S. Food and Drug Administration
Published: 2014-07-18

Substantially Equivalent

Neuroinvent, Inc.

FDA 510(k) clearance K140200 for E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES, Substantially Equivalent on 2014-07-18. 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: 2014-01-27
Decision date: 2014-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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