The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson S8/ Voluson S10/ Voluson S10 Expert.
| Device ID | K180374 |
| 510k Number | K180374 |
| Device Name: | Voluson S8/ 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682143820 | K180374 | 000 |
| 00195278473042 | K180374 | 000 |
| 00195278473059 | K180374 | 000 |
| 00195278473066 | K180374 | 000 |
| 00195278473073 | K180374 | 000 |
| 00195278473080 | K180374 | 000 |
| 00840682125420 | K180374 | 000 |
| 00840682138185 | K180374 | 000 |
| 00840682138215 | K180374 | 000 |
| 00840682138239 | K180374 | 000 |
| 00195278473028 | K180374 | 000 |