Cleared Traditional

NEUROVISION NERVE LOCATOR MONITOR

K110140 · Neurovision Medical Products, Inc. · Neurology
Sep 2011
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K110140 is an FDA 510(k) clearance for the NEUROVISION NERVE LOCATOR MONITOR, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on September 30, 2011, 255 days after receiving the submission on January 18, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K110140 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2011
Decision Date September 30, 2011
Days to Decision 255 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

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