U.S. FDA Medical Device Stereo Campimeter Requirements
FDA Medical Device Definition: A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.
FDA Stereo Campimeter Label Requirements and Exceptions
FDA Stereo Campimeter Import Information
FDA Stereo Campimeter Detentions (Stereo Campimeter Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Stereo Campimeter Manufacturers (Stereo Campimeter Suppliers)
- Stereo Campimeter Distributors
- Stereo Campimeter Processors
- Stereo Campimeter Repackers
- Stereo Campimeter Relabelers
- Stereo Campimeter Exporters
- Stereo Campimeter Importers
For more information about Stereo Campimeter 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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