Cleared Special

NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

K130806 · Neurovision Medical Products, Inc. · Neurology

Jul 2013

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K130806 is an FDA 510(k) clearance for the NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on July 12, 2013, 109 days after receiving the submission on March 25, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K130806 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2013
Decision Date	July 12, 2013
Days to Decision	109 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PDQ — Neurosurgical Nerve Locator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.1820
Definition	To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.