The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Echoscan, Model Us-1800.
| Device ID | K020876 |
| 510k Number | K020876 |
| Device Name: | ECHOSCAN, MODEL US-1800 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-18 |
| Decision Date | 2002-05-03 |
| Summary: | summary |