HJG · System, Reading, Television, Closed-Circuit
Ophthalmic · 21 CFR 886.5820 · Class 1
Overview
| Product Code | HJG |
|---|---|
| Device Name | System, Reading, Television, Closed-Circuit |
| Regulation | 21 CFR 886.5820 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K933633 | LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE | Gracefully Yours, Inc. | Feb 22, 1994 | SESE |
| K915340 | MENTOR HORIZON LOW VISION MAGNIFIER | Mentor O & O, Inc. | Mar 30, 1992 | SESE |
| K920069 | MAGNI-CAM | Innoventions, Inc. | Mar 2, 1992 | SESE |
| K892351 | MAGNILINK SYSTEM 602 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
| K892350 | MAGNILINK SYSTEM 402/5 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
| K892349 | MAGNILINK SYSTEM 209 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
| K892348 | MAGNILINK SYSTEM 201 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
| K892347 | MAGNILINK SYSTEM 101 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
Top Applicants
- Coburn Optical Ind., Inc. — 5 clearances
- Gracefully Yours, Inc. — 1 clearance
- Innoventions, Inc. — 1 clearance
- Mentor O & O, Inc. — 1 clearance
