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U.S. FDA Medical Device Oxygen Tent Requirements

FDA Medical Device Definition: A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.

Registrar Corp assists Oxygen Tent companies with:

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