Interacoustics Model AZ26 Clinical Impedance Audiometer

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

510(k) Number

K990652 ↗

FDA Product Code

ETY

Device Class

Class II

Regulation

21 CFR Part 874.1090

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K981327 Active Cleared 11 May 1998

• Interacoustics AT22T Automatic Impedance Audiometer

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  FDA 510(k) K990585 Active Cleared 17 May 1999

• Interacoustics Ep 15 Abr Stand Alone Unit

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• Interacoustics Model AD229 Diagnostic Audiometer

  Class II

  FDA 510(k) K982249 Active Cleared 7 Aug 1998

• Interacoustics Model Mt 10, Handheld Impedance Audiometer

  Class II

  FDA 510(k) K983832 Active Cleared 25 Jan 1999

• What is the Interacoustics Model AZ26 Clinical Impedance Audiometer intended for?

  The device is intended to change air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. It is used by clinicians to perform diagnostic hearing evaluations, including tympanometry, acoustic reflex, and air conduction audiometry.

• How is the Interacoustics Model AZ26 supplied and is it sterile or reusable?

  The device is supplied as a non-sterile, reusable device for use in clinical settings such as audiology or ENT clinics. It is not provided sterile and is designed for repeated use after appropriate cleaning and maintenance between patients.

• What regulatory pathway was used for the Interacoustics Model AZ26, and what is its classification?

  The device received FDA 510(k) clearance under K990652, determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under regulation number 874.1090, with product code ETY, and falls under the Ear, Nose, Throat medical specialty.