Race Car Tympanometer with Audiometer(Ae-Rcaud I/Quik Tymp 1(Ae-Quik 1)/Quick Tymp 2(Ae-Quik 2)

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

510(k) Number

K970279 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Immittance Meter, Model Ae-105D/S

  Class II

  FDA 510(k) K905212 Active Cleared 19 Feb 1991

• The Screening Tympanometer

  Class II

  FDA 510(k) K822745 Active Cleared 30 Sep 1982

• 629V Spirometer, Pulmonary Function Analyzer

  Class II

  FDA 510(k) K881402 Active Cleared 26 Sep 1988

• American Electromedics Quik Tymp 1 (QT1) Tympanometer with Intergral Printer

  Class II

  FDA 510(k) K983049 Active Cleared 18 Nov 1998

• Echosine 1000, Pulsed a-Mode Ultrasound Device

  Not classified

  FDA 510(k) K837029 Active Cleared 22 Mar 1983

• Automatic Impedance Meter Ae-205

  Class II

  FDA 510(k) K924934 Active Cleared 21 Jan 1993

See all devices from American Electromedics Corp. →

• What is the Race Car Audiometer Tympanometer used for?

  The Race Car Audiometer Tympanometer (AE-RCAUD I/QUIK TYMP) is designed for ear, nose, and throat (ENT) medical evaluations. It combines audiometry and tympanometry functions, allowing clinicians to assess hearing thresholds and middle ear function in a single session. This dual-purpose device streamlines diagnostic testing, improving efficiency in ENT examinations.

• What models are included in the Race Car Audiometer Tympanometer lineup?

  The Race Car Audiometer Tympanometer includes three distinct models: AE-RCAUD I, Quik Tymp 1 (AE-QUIK 1), and Quick Tymp 2 (AE-QUIK 2). Each model retains the core audiometer and tympanometer capabilities, ensuring versatility for different clinical needs while maintaining compatibility with the same regulatory framework.

• Is the Race Car Audiometer Tympanometer single-use or reusable?

  The device is intended for reusable clinical use. While the provided data does not specify sterilization methods, reusable audiometric and tympanometric devices typically require proper cleaning and disinfection between patients to maintain hygiene and functionality. Always follow manufacturer guidelines for maintenance and reprocessing.

• What regulatory approval does the Race Car Audiometer Tympanometer hold?

  The Race Car Audiometer Tympanometer holds FDA 510K clearance under the regulation number 874.1050. This classification indicates it has been deemed substantially equivalent to a predicate device and falls under Class II medical devices, which require traditional clearance through the FDA’s 510(k) process.

• How should the Race Car Audiometer Tympanometer be stored?

  While specific storage instructions are not detailed in the provided data, reusable audiometric and tympanometric devices generally require protection from physical damage, extreme temperatures, and humidity. Store the device in a clean, dry environment, away from direct sunlight or sources of electromagnetic interference, to preserve its calibration and functionality for accurate diagnostic use.