Cleared Traditional

AURICAL HIT

K122028 · Gn Otometrics · Ear, Nose, Throat
Oct 2012
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K122028 is an FDA 510(k) clearance for the AURICAL HIT, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Gn Otometrics (Naples, US). The FDA issued a Cleared decision on October 23, 2012, 105 days after receiving the submission on July 10, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K122028 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2012
Decision Date October 23, 2012
Days to Decision 105 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3310

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