The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson P6, Voluson P8.
| Device ID | K160162 |
| 510k Number | K160162 |
| Device Name: | Voluson P6, Voluson P8 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE HEALTHCARE 9900 W INNOVATION DR Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE HEALTHCARE 9900 W INNOVATION DR 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 | 2016-01-27 |
| Decision Date | 2016-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104166 | K160162 | 000 |
| 00840682116527 | K160162 | 000 |
| 00840682108553 | K160162 | 000 |
| 00840682106870 | K160162 | 000 |
| 00840682105255 | K160162 | 000 |
| 00840682105026 | K160162 | 000 |
| 00840682104968 | K160162 | 000 |
| 00840682104326 | K160162 | 000 |