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U.S. FDA Medical Device Auditory Impedance Tester Requirements: Auditory Impedance Tester

FDA Medical Device Definition: An auditory impedance tester is a device that is intended to change the 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. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear

Registrar Corp assists Auditory Impedance Tester companies with:

  • FDA Auditory Impedance Tester Establishment Registration
  • FDA Auditory Impedance Tester Listing
  • FDA Auditory Impedance Tester Label Requirements and Exceptions
  • FDA Auditory Impedance Tester Import Information
  • FDA Auditory Impedance Tester Detentions (Auditory Impedance Tester Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Auditory Impedance Tester Manufacturers (Auditory Impedance Tester Suppliers)
       - Auditory Impedance Tester Distributors
       - Auditory Impedance Tester Processors
       - Auditory Impedance Tester Repackers
       - Auditory Impedance Tester Relabelers
       - Auditory Impedance Tester Exporters
       - Auditory Impedance Tester Importers
For more information about Auditory Impedance Tester Medical Devices, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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