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U.S. FDA Medical Device Hearing Aid Calibrator and Analysis System Requirements: Hearing Aid Calibrator and Analysis System

FDA Medical Device Definition: A hearing aid calibrator and analysis system 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 and Analysis System companies with:

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