Cleared Traditional

K103760 - TITAN (FDA 510(k) Clearance)

K103760 · Interacoustics A/S · Neurology device
May 2011
Decision
133d
Days
Class 2
Risk

K103760 is an FDA 510(k) clearance for the TITAN. This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).

Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on May 5, 2011, 133 days after receiving the submission on December 23, 2010.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K103760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2010
Decision Date May 05, 2011
Days to Decision 133 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWJ - Stimulator, Auditory, Evoked Response
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.1900