The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Auto Refractometer.
| Device ID | K831083 |
| 510k Number | K831083 |
| Device Name: | AUTO REFRACTOMETER |
| Classification | Refractometer, Ophthalmic |
| Applicant | NIDEK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-06-10 |