The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Rt-1200s (marco Trs-1200).
| Device ID | K901513 |
| 510k Number | K901513 |
| Device Name: | NIDEK RT-1200S (MARCO TRS-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 | 1990-03-30 |
| Decision Date | 1990-06-08 |