The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And with the FDA for Vivid E80/ Vivid E90/ Vivid E95.
| Device ID | K200743 |
| 510k Number | K200743 |
| Device Name: | Vivid E80/ Vivid E90/ Vivid E95 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE Medical Systems Ultrasound And Primary Care Diagnotics, 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 | 2020-03-23 |
| Decision Date | 2020-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682142366 | K200743 | 000 |
| 00840682147064 | K200743 | 000 |
| 00840682146685 | K200743 | 000 |
| 00195278341235 | K200743 | 000 |
| 00840682146654 | K200743 | 000 |