The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Site-rite 8 Ultrasound System, Site-rite 8 Ultrasound System With Pinpoint Gt Technology.
| Device ID | K152554 |
| 510k Number | K152554 |
| Device Name: | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System With Pinpoint GT Technology |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Kerrie Hamblin |
| Correspondent | Kerrie Hamblin C.R. Bard, Inc. 605 North 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 | 2015-09-08 |
| Decision Date | 2015-12-14 |
| Summary: | summary |