Battery-Powered Stereoscope Suppliers
www.amaoptics.com | Send Inquiry | Phone: +1-(305)-389-0928
FDA Registration: 3004571972
Products: Potential Vision Testing, Near Visual Acuity Charts, Visual Acuity Charts (FDA Code: HOX), Vision Testing, ETDRS Visual Acuity Charts, Vision Testing, Near Visual Acuity Charts, Battery-Powered Stereoscope (FDA Code: HJR), ...
AMA Optics, Inc. produces potential vision testers that help doctors to distinguish between vision loss from cataract and the vision loss from maculopathy. We offer products such as retinal acuity met more...
A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye 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.
