Cleared Traditional

EARPROBE

K131141 · Path Medical GmbH · Neurology
Jun 2013
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K131141 is an FDA 510(k) clearance for the EARPROBE, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Path Medical GmbH (Germering, Bavaria, DE). The FDA issued a Cleared decision on June 27, 2013, 65 days after receiving the submission on April 23, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K131141 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2013
Decision Date June 27, 2013
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900