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 | K220882 |
| 510k Number | K220882 |
| 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 | Lee Bush GE Medical Systems Ultrasound And 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 | 2022-03-25 |
| Decision Date | 2022-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278388483 | K220882 | 000 |
| 00195278516343 | K220882 | 000 |
| 00195278505354 | K220882 | 000 |
| 00195278505347 | K220882 | 000 |
| 00195278505330 | K220882 | 000 |