HOW · Drum, Opticokinetic
Ophthalmic · 21 CFR 886.1200 · Class 1
Overview
| Product Code | HOW |
|---|---|
| Device Name | Drum, Opticokinetic |
| Regulation | 21 CFR 886.1200 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.
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 |
|---|---|---|---|---|
| K822917 | MODEL 5400 OPTOKINETIC STIMULATOR | Life-Tech Intl., Inc. | Nov 1, 1982 | SESE |
Top Applicants
- Life-Tech Intl., Inc. — 1 clearance
