The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Us-1600 A-scan.
| Device ID | K854389 |
| 510k Number | K854389 |
| Device Name: | NIDEK US-1600 A-SCAN |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | John Bratkowsky |
| Correspondent | John Bratkowsky 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 | 1985-10-31 |
| Decision Date | 1986-04-08 |