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U.S. FDA Medical Device Oxygen Mask Requirements

FDA Medical Device Definition: An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

Registrar Corp assists Oxygen Mask companies with:

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