The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics with the FDA for Vivid S60n / Vivid S70n.
| Device ID | K211216 |
| 510k Number | K211216 |
| Device Name: | Vivid S60N / Vivid S70N |
| 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 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 | 2021-04-23 |
| Decision Date | 2021-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278276322 | K211216 | 000 |
| 00195278276285 | K211216 | 000 |
| 00195278276261 | K211216 | 000 |
| 00195278406866 | K211216 | 000 |
| 00195278276278 | K211216 | 000 |