(a)Identification. A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]