HJY · Reader, Bar, Ophthalmic
Ophthalmic · 21 CFR 886.5800 · Class 1
Overview
| Product Code | HJY |
|---|---|
| Device Name | Reader, Bar, Ophthalmic |
| Regulation | 21 CFR 886.5800 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.
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. The 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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K781459 | MONOJECT SCALE MAGNIFIER | Sherwood Medical Industries | Oct 24, 1978 | SESE |
Top Applicants
- Sherwood Medical Industries — 1 clearance
