NIDEK ARK-2000
Device Facts
| Record ID | K882191 |
|---|---|
| Device Name | NIDEK ARK-2000 |
| Applicant | Nidek, Inc. |
| Product Code | HKO · Ophthalmic |
| Decision Date | Jul 1, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1760 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.
