21 CFR 886.1070 — Anomaloscope
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1070
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HIW | Anomaloscope | 1 | 3 |
