The following data is part of a premarket notification filed by Paradigm Medical Industries, Inc. with the FDA for Ubm Plus, Model P45.
| Device ID | K003141 |
| 510k Number | K003141 |
| Device Name: | UBM PLUS, MODEL P45 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PARADIGM MEDICAL INDUSTRIES, INC. 2355 SOUTH 1070 WEST Salt Lake City, UT 84119 |
| Contact | Tracy S Best |
| Correspondent | Tracy S Best PARADIGM MEDICAL INDUSTRIES, INC. 2355 SOUTH 1070 WEST Salt Lake City, UT 84119 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2000-12-05 |