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U.S. FDA Medical Device Hearing Aid Calibrator Requirements: Hearing Aid Calibrator

FDA Medical Device Definition: A hearing aid calibrator is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box

Registrar Corp assists Hearing Aid Calibrator companies with:

  • FDA Hearing Aid Calibrator Establishment Registration
  • FDA Hearing Aid Calibrator Listing
  • FDA Hearing Aid Calibrator Label Requirements and Exceptions
  • FDA Hearing Aid Calibrator Import Information
  • FDA Hearing Aid Calibrator Detentions (Hearing Aid Calibrator Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Hearing Aid Calibrator Manufacturers (Hearing Aid Calibrator Suppliers)
       - Hearing Aid Calibrator Distributors
       - Hearing Aid Calibrator Processors
       - Hearing Aid Calibrator Repackers
       - Hearing Aid Calibrator Relabelers
       - Hearing Aid Calibrator Exporters
       - Hearing Aid Calibrator Importers
For more information about Hearing Aid Calibrator 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.


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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