U.S. FDA Medical Device Opticokinetic Drum Requirements
FDA Medical Device Definition: An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.
FDA Opticokinetic Drum Label Requirements and Exceptions
FDA Opticokinetic Drum Import Information
FDA Opticokinetic Drum Detentions (Opticokinetic Drum Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Opticokinetic Drum Manufacturers (Opticokinetic Drum Suppliers)
- Opticokinetic Drum Distributors
- Opticokinetic Drum Processors
- Opticokinetic Drum Repackers
- Opticokinetic Drum Relabelers
- Opticokinetic Drum Exporters
- Opticokinetic Drum Importers
For more information about Opticokinetic Drum 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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