The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for The Esi-2000 Ultrasound Unit.
| Device ID | K874683 |
| 510k Number | K874683 |
| Device Name: | THE ESI-2000 ULTRASOUND UNIT |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ELSCINT, INC. 751 EXPRESSWAY DR. Itasca, IL 60143 |
| Contact | Robert E Kenney |
| Correspondent | Robert E Kenney ELSCINT, INC. 751 EXPRESSWAY DR. Itasca, IL 60143 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-18 |
| Decision Date | 1988-04-18 |