Cleared Traditional

HEARLAB ACA

K123701 · Frye Electronics, Inc. · Neurology
Apr 2013
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K123701 is an FDA 510(k) clearance for the HEARLAB ACA, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Frye Electronics, Inc. (Tigard, US). The FDA issued a Cleared decision on April 5, 2013, 123 days after receiving the submission on December 3, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K123701 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2012
Decision Date April 05, 2013
Days to Decision 123 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

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