The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Ar-1200.
| Device ID | K890559 |
| 510k Number | K890559 |
| Device Name: | NIDEK AR-1200 |
| Classification | Refractometer, Ophthalmic |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | Ken Kato |
| Correspondent | Ken Kato NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-02-27 |