The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc with the FDA for Vivid T8, Vivid T9.
| Device ID | K181934 |
| 510k Number | K181934 |
| Device Name: | Vivid T8, Vivid T9 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 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 | 2018-07-19 |
| Decision Date | 2018-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682139199 | K181934 | 000 |
| 00840682139182 | K181934 | 000 |