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Interacoustics AT22T Automatic Impedance Audiometer

by Idem (Int'L Dist. of Electronics For Medicine)

510(k) K990585

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990585 Date17 May 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ETY
Device Class
Class II
Regulation
21 CFR Part 874.1090
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Interacoustics AT22T Automatic Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals for conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

The device is supplied by Idem (Int'L Dist. of Electronics For Medicine) and is classified as a Tester, Auditory Impedance with product code ETY. It received FDA 510(k) clearance with number K990585 on May 17, 1999, as substantially equivalent to predicate devices. The device is intended for use in ear, nose, and throat diagnostic settings.

Other devices from Idem (Int'L Dist. of Electronics For Medicine)

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Interacoustics AT22T Automatic Impedance Audiometer used for?

    The AT22T is an electroacoustic test instrument that produces controlled levels of test tones and signals for conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry capabilities.

  • How is the Interacoustics AT22T supplied and what is its regulatory status?

    The device is supplied by Idem (Int'L Dist. of Electronics For Medicine) and received FDA 510(k) clearance with number K990585 on May 17, 1999, as substantially equivalent to predicate devices. It is intended for use in ear, nose, and throat diagnostic settings.

  • What are the key features of the Interacoustics AT22T Automatic Impedance Audiometer?

    The AT22T is classified as a Tester, Auditory Impedance with product code ETY. It provides comprehensive testing capabilities including tympanometry, acoustic reflex testing, and air conduction audiometry to support diagnostic evaluations in audiology and otology practices.