U.S. FDA Medical Device Artificial Nose Requirements
FDA Medical Device Definition: A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
Registrar Corp assists Artificial Nose companies with:
FDA Artificial Nose Establishment Registration
FDA Artificial Nose Listing
FDA Artificial Nose Label Requirements and Exceptions
FDA Artificial Nose Import Information
FDA Artificial Nose Detentions (Artificial Nose Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Artificial Nose Manufacturers (Artificial Nose Suppliers)
- Artificial Nose Distributors
- Artificial Nose Processors
- Artificial Nose Repackers
- Artificial Nose Relabelers
- Artificial Nose Exporters
- Artificial Nose Importers
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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.