Cleared Traditional

EARPROBE

K100661 · Path Medical GmbH · Neurology
Jul 2010
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K100661 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 (Fort Collins, US). The FDA issued a Cleared decision on July 1, 2010, 115 days after receiving the submission on March 8, 2010. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K100661 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2010
Decision Date July 01, 2010
Days to Decision 115 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