HLS · Exophthalmometer
Ophthalmic · 21 CFR 886.1270 · Class 1
Overview
| Product Code | HLS |
|---|---|
| Device Name | Exophthalmometer |
| Regulation | 21 CFR 886.1270 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K771900 | 71110 DESK CHARGER | Welch Allyn, Inc. | Nov 9, 1977 | SESE |
Top Applicants
- Welch Allyn, Inc. — 1 clearance
