The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Diagnostic Ultrasound Sys Model Uls1000.
| Device ID | K850580 |
| 510k Number | K850580 |
| Device Name: | DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ELSCINT, INC. 775 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
| Contact | Robert E Kenney |
| Correspondent | Robert E Kenney ELSCINT, INC. 775 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-13 |
| Decision Date | 1985-04-03 |