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.
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.
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