The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert.
| Device ID | K213642 |
| 510k Number | K213642 |
| Device Name: | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Healthcare 9900 Innovation DRive Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Healthcare 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 | 2021-11-18 |
| Decision Date | 2022-01-13 |