The following data is part of a premarket notification filed by C.r. Bard with the FDA for Site~rite 8 Ultrasound System With Cue Needle Tracking System And Pinpoint Gt Needle Tech.
| Device ID | K182281 |
| 510k Number | K182281 |
| Device Name: | Site~Rite 8 Ultrasound System With Cue Needle Tracking System And Pinpoint GT Needle Tech |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | C.R. Bard 605 N 5600 West Salt Lake City, UT 84116 |
| Contact | Sari Stevens |
| Correspondent | Sari Stevens C.R. Bard 605 N 5600 West Salt Lake City, UT 84116 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-23 |
| Decision Date | 2018-10-24 |
| Summary: | summary |