The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson E6, Voluson E8, Voluson E10.
| Device ID | K192159 |
| 510k Number | K192159 |
| Device Name: | Voluson E6, Voluson E8, Voluson E10 |
| 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 | 2019-08-09 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146890 | K192159 | 000 |
| 00195278077592 | K192159 | 000 |
| 00195278016836 | K192159 | 000 |
| 00195278016829 | K192159 | 000 |
| 00195278016812 | K192159 | 000 |