Cleared Traditional

K130795 - TITAN (FDA 510(k) Clearance)

K130795 · Interacoustics A/S · Ear, Nose, Throat device
Jun 2013
Decision
90d
Days
Class 2
Risk

K130795 is an FDA 510(k) clearance for the TITAN. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).

Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on June 20, 2013, 90 days after receiving the submission on March 22, 2013.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K130795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2013
Decision Date June 20, 2013
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWO - Audiometer
Device Class Class II - Special Controls
CFR Regulation 21 CFR 874.1050