Audiotraveller, Model AA222

FDA 510(k) K022728 · Interacoustics A/S, Assens

Substantially Equivalent

510(k) numberK022728

Submission

Device name
Audiotraveller, Model AA222
Applicant
Interacoustics A/S, Assens
Eden Prairie, MN, US
Received
August 16, 2002
Decision date
October 11, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ETY – Tester, Auditory Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1090
Specialty
Ear, Nose, Throat

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Questions and answers

When was Audiotraveller, Model AA222 cleared by the FDA?

Audiotraveller, Model AA222 (K022728) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 56 days after the submission was received.

What is the product code of K022728?

The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.