Cleared Traditional

AUDIOTRAVELLER, MODEL AA222

K022728 · Interacoustics A/S, Assens · Ear, Nose, Throat

Oct 2002

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K022728 is an FDA 510(k) clearance for the AUDIOTRAVELLER, MODEL AA222, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Interacoustics A/S, Assens (Eden Prairie, US). The FDA issued a Cleared decision on October 11, 2002, 56 days after receiving the submission on August 16, 2002. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number	K022728 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2002
Decision Date	October 11, 2002
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement