The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson E6 / E8 / E8expert / E8expert Limited Edition / E10.
| Device ID | K132913 |
| 510k Number | K132913 |
| Device Name: | VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE HEALTHCARE 9900 W INNOVATION DRIVE Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE HEALTHCARE 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-17 |
| Decision Date | 2013-11-08 |
| Summary: | summary |