21 CFR 886.5820 — System, Reading, Television, Closed-Circuit
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5820
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HJG | System, Reading, Television, Closed-Circuit | 1 | 8 |
