Cleared Traditional

TEOAE25

K030016 · Interacoustics A/S, Assens · Ear, Nose, Throat
Mar 2003
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K030016 is an FDA 510(k) clearance for the TEOAE25, a Audiometer (Class II — Special Controls, product code EWO), submitted by Interacoustics A/S, Assens (Eden Prairie, US). The FDA issued a Cleared decision on March 28, 2003, 85 days after receiving the submission on January 2, 2003. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K030016 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2003
Decision Date March 28, 2003
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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