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U.S. FDA Medical Device Heat & Moisture Condenser Requirements


FDA Medical Device Definition: A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

Registrar Corp assists Heat & Moisture Condenser companies with:

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