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U.S. FDA Medical Device Breathing Circuit Requirements

FDA Medical Device Definition: An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Registrar Corp assists Breathing Circuit companies with:

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