Cleared Traditional

TYPE 1077 ACCUSCREEN

K122067 · Gn Otometrics · Neurology
Sep 2012
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K122067 is an FDA 510(k) clearance for the TYPE 1077 ACCUSCREEN, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Gn Otometrics (Taastrup, DK). The FDA issued a Cleared decision on September 27, 2012, 73 days after receiving the submission on July 16, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K122067 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2012
Decision Date September 27, 2012
Days to Decision 73 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