Cleared Traditional

MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM

K120397 · Nihon Kohden Corp. · Neurology
Sep 2012
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K120397 is an FDA 510(k) clearance for the MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on September 19, 2012, 224 days after receiving the submission on February 8, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K120397 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2012
Decision Date September 19, 2012
Days to Decision 224 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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