HRK · Table, Instrument, Manual, Ophthalmic
Ophthalmic · 21 CFR 886.4855 · Class 1
Overview
| Product Code | HRK |
|---|---|
| Device Name | Table, Instrument, Manual, Ophthalmic |
| Regulation | 21 CFR 886.4855 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed.
Classification Rationale
Class I (general controls). The AC-powered device and the manual 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 manual 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 (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K842410 | AMER. EDWARDS LAB FLEXISCOPE | American Edwards Laboratories | Nov 5, 1984 | SESE |
| K760697 | EVANS ARM AND HAND REST | Alcon Laboratories | Nov 2, 1976 | SESE |
Top Applicants
- American Edwards Laboratories — 1 clearance
- Alcon Laboratories — 1 clearance
