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U.S. FDA Medical Device Audiometer Calibration Set Requirements


FDA Medical Device Definition: An audiometer calibration set is an electronic reference device that is intended to calibrate an audiometer. It measures the sound frequency and intensity characteristics that emanate from an audiometer earphone. The device consists of an acoustic cavity of known volume, a sound level meter, a microphone with calibration traceable to the National Bureau of Standards, oscillators, frequency counters, microphone amplifiers, and a recorder. The device can measure selected audiometer test frequencies at a given intensity level, and selectable audiometer attenuation settings at a given test frequency.

Registrar Corp assists Audiometer Calibration Set companies with:

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






 
U.S. FDA Regulations:

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


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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