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U.S. FDA Medical Device Hyperbaric Chamber Requirements: Hyperbaric Chamber

FDA Medical Device Definition: A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (878.5650)

Registrar Corp assists Hyperbaric Chamber companies with:

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

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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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