The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Site-rite Prevue Ultrasound System, Site-rite Prevue+ Ultrasound System.
| Device ID | K150529 |
| 510k Number | K150529 |
| Device Name: | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | C.R. Bard, Inc 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Reily Inman |
| Correspondent | Reily Inman C.R. Bard, Inc 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-03-30 |
| Summary: | summary |