Battery-Powered Spectacle Dissociation Test Suppliers
www.guldenindustries.com | Send Inquiry | Phone: +1-(215)-884-8105, 800-659-2250
FDA Registration: 2518410 Year Established: 1938 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Eye Shields, Human Eye Model, Eye Gel Mask, Eye Tonometer, Eye Guards, Gel Eye Shields, ...
Gulden Ophthalmic is a manufacturer of ophthalmic instruments and devices. Our product list comprises of cornea eye models, detachment eye models and lighted low vision pens. Our lighted low vision pe more...
A spectacle dissociation test system is an AC-powered or battery-powered device, such as a Lancaster test system, that consists of a light source and various filters, usually red or green filters, intended to subjectively measure imbalance of ocular muscles.
Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
