HIW · Anomaloscope
Ophthalmic · 21 CFR 886.1070 · Class 1
Overview
| Product Code | HIW |
|---|---|
| Device Name | Anomaloscope |
| Regulation | 21 CFR 886.1070 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient.
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930575 | KAMPPETER ANOMALOSCOPE | Bova Intl. | Feb 25, 1994 | SESE |
| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | Lkc Technologies, Inc. | Oct 23, 1991 | SESE |
| K860174 | GUNKEL CHROMAGRAPH COLOR VISION TESTER | Chromagraphics, Inc. | Apr 4, 1986 | SESE |
Top Applicants
- Bova Intl. — 1 clearance
- Chromagraphics, Inc. — 1 clearance
- Lkc Technologies, Inc. — 1 clearance
