HIX · Maxwell Spot, Ac-Powered
Ophthalmic · 21 CFR 886.1435 · Class 1
Overview
| Product Code | HIX |
|---|---|
| Device Name | Maxwell Spot, Ac-Powered |
| Regulation | 21 CFR 886.1435 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.
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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831829 | KARICKHOFF FLYING CORPUSCLE VIEWER | Surgidev Corp. | Oct 19, 1983 | SESE |
| K801554 | STERILE CAST PADDING | Medi-Spec | Aug 4, 1980 | SESE |
Top Applicants
- Surgidev Corp. — 1 clearance
- Medi-Spec — 1 clearance
