Cleared Traditional

OTODYNAMICS OTOPORT

K072033 · Otodynamics, Ltd. · Ear, Nose, Throat
Nov 2007
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K072033 is an FDA 510(k) clearance for the OTODYNAMICS OTOPORT, a Audiometer (Class II — Special Controls, product code EWO), submitted by Otodynamics, Ltd. (Crofton, US). The FDA issued a Cleared decision on November 13, 2007, 112 days after receiving the submission on July 24, 2007. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K072033 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2007
Decision Date November 13, 2007
Days to Decision 112 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