The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics with the FDA for Voluson Swift, Voluson Swift+.
| Device ID | K201828 |
| 510k Number | K201828 |
| Device Name: | Voluson SWIFT, Voluson SWIFT+ |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Medical Systems Ultrasound And Primary Care Diagnostics 9900 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 | 2020-07-02 |
| Decision Date | 2020-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682147507 | K201828 | 000 |
| 00195278006837 | K201828 | 000 |
| 00195278006820 | K201828 | 000 |