Cleared Traditional

Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

K143395 · Otodynamics, Ltd. · Ear, Nose, Throat

Feb 2015

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K143395 is an FDA 510(k) clearance for the Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit, a Audiometer (Class II — Special Controls, product code EWO), submitted by Otodynamics, Ltd. (Hatfield, Herts, GB). The FDA issued a Cleared decision on February 23, 2015, 89 days after receiving the submission on November 26, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K143395 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2014
Decision Date	February 23, 2015
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF