Cleared Special

Madsen Zodiac

K161707 · Gn Otometrics · Ear, Nose, Throat
Sep 2016
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K161707 is an FDA 510(k) clearance for the Madsen Zodiac, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Gn Otometrics (Taastrup, DK). The FDA issued a Cleared decision on September 1, 2016, 72 days after receiving the submission on June 21, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number K161707 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2016
Decision Date September 01, 2016
Days to Decision 72 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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