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.
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.
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