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U.S. FDA Medical Device Caloric-Air Stimulator Requirements

FDA Medical Device Definition: An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.

Registrar Corp assists Caloric-Air Stimulator companies with:

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