Cleared Traditional

MADSEN ACCUSCREEN TYPE 1077

K132957 · Gn Otometrics · Neurology
Feb 2014
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K132957 is an FDA 510(k) clearance for the MADSEN ACCUSCREEN TYPE 1077, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Gn Otometrics (Naples, US). The FDA issued a Cleared decision on February 27, 2014, 160 days after receiving the submission on September 20, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K132957 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2013
Decision Date February 27, 2014
Days to Decision 160 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