The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Additional Features Esi-3000 Ultrasound Unit.
| Device ID | K925627 |
| 510k Number | K925627 |
| Device Name: | ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Rochelle M Sobel |
| Correspondent | Rochelle M Sobel ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-06 |
| Decision Date | 1993-10-08 |