The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson E6/e8/e8expert/e10.
| Device ID | K122327 |
| 510k Number | K122327 |
| Device Name: | VOLUSON E6/E8/E8EXPERT/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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118712 | K122327 | 000 |
| 00840682118675 | K122327 | 000 |