The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Up-2000.
| Device ID | K880065 |
| 510k Number | K880065 |
| Device Name: | NIDEK UP-2000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | Carl R Jordan |
| Correspondent | Carl R Jordan NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-07 |
| Decision Date | 1988-03-15 |