U.S. FDA Medical Device Vacuum Regulator Requirements
FDA Medical Device Definition: A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
FDA Vacuum Regulator Label Requirements and Exceptions
FDA Vacuum Regulator Import Information
FDA Vacuum Regulator Detentions (Vacuum Regulator Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Vacuum Regulator Manufacturers (Vacuum Regulator Suppliers)
- Vacuum Regulator Distributors
- Vacuum Regulator Processors
- Vacuum Regulator Repackers
- Vacuum Regulator Relabelers
- Vacuum Regulator Exporters
- Vacuum Regulator Importers
For more information about Vacuum Regulator 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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