Cleared Traditional

NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

K110989 · Neurovision Medical Products, Inc. · Ear, Nose, Throat
Nov 2011
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K110989 is an FDA 510(k) clearance for the NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on November 3, 2011, 209 days after receiving the submission on April 8, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K110989 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2011
Decision Date November 03, 2011
Days to Decision 209 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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