Cleared Traditional

TITAN

K121847 · Interacoustics A/S · Ear, Nose, Throat
Nov 2012
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K121847 is an FDA 510(k) clearance for the TITAN, 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 November 29, 2012, 157 days after receiving the submission on June 25, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number K121847 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2012
Decision Date November 29, 2012
Days to Decision 157 days
Submission Type Traditional
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