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U.S. FDA Medical Device Carbon-Dioxide Absorber Requirements


FDA Medical Device Definition: A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain.

Registrar Corp assists Carbon-Dioxide Absorber companies with:

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