The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Ultra Imager 2000.
| Device ID | K834282 |
| 510k Number | K834282 |
| Device Name: | ULTRA IMAGER 2000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HONEYWELL, INC. IN |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-21 |
| Decision Date | 1984-04-23 |