The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnotics, L with the FDA for Vivid T8.
| Device ID | K160078 |
| 510k Number | K160078 |
| Device Name: | Vivid T8 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnotics, L 9900 W. Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE Medical Systems Ultrasound And Primary Care Diagnotics, L 9900 W. Innovation Drive Wauwatosa, WI 53226 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-14 |
| Decision Date | 2016-03-10 |
| Summary: | summary |