HOJ · Screen, Tangent, Target
Ophthalmic · 21 CFR 886.1810 · Class 1
Overview
| Product Code | HOJ |
|---|---|
| Device Name | Screen, Tangent, Target |
| Regulation | 21 CFR 886.1810 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.
Classification Rationale
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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K873919 | TANGENT SCREEN | Richmond Products, Inc. | Oct 28, 1987 | SESE |
| K844657 | SPECTABLE FRAME MAGNIFYING BRILLETTE | Pro Design Intl. AS | Dec 11, 1984 | SESE |
| K821081 | CHART PROJECTOR | Medical Equipment Designs, Inc. | Jun 14, 1982 | SESE |
Top Applicants
- Richmond Products, Inc. — 1 clearance
- Pro Design Intl. AS — 1 clearance
- Medical Equipment Designs, Inc. — 1 clearance
