21 CFR 886.1270 — Exophthalmometer
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1270
Identification
An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).
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 |
|---|---|---|---|---|
| HLS | Exophthalmometer | 1 | 1 |
