U.S. FDA Medical Device Manual Perimeter Requirements
FDA Medical Device Definition: A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
FDA Manual Perimeter Label Requirements and Exceptions
FDA Manual Perimeter Import Information
FDA Manual Perimeter Detentions (Manual Perimeter Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Manual Perimeter Manufacturers (Manual Perimeter Suppliers)
- Manual Perimeter Distributors
- Manual Perimeter Processors
- Manual Perimeter Repackers
- Manual Perimeter Relabelers
- Manual Perimeter Exporters
- Manual Perimeter Importers
For more information about Manual Perimeter 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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