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U.S. FDA Medical Device Humidifier for Home-Use Requirements


FDA Medical Device Definition: A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration.

Registrar Corp assists Humidifier for Home-Use companies with:

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