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U.S. FDA Medical Device Non-Rebreathing Oxygen Mask Requirements


FDA Medical Device Definition: A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.

Registrar Corp assists Non-Rebreathing Oxygen Mask companies with:

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