The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Esi 2000 Diagnostic Ultrasound System Transducers.
| Device ID | K860081 |
| 510k Number | K860081 |
| Device Name: | ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS |
| 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 | 1986-01-08 |
| Decision Date | 1986-06-16 |