Cleared Special

AT235

K151616 · Interacoustics A/S · Ear, Nose, Throat
Jul 2015
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K151616 is an FDA 510(k) clearance for the AT235, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on July 15, 2015, 30 days after receiving the submission on June 15, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number K151616 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2015
Decision Date July 15, 2015
Days to Decision 30 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETY — Tester, Auditory Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1090

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