The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson P6 And Voluson P8.
| Device ID | K180535 |
| 510k Number | K180535 |
| Device Name: | Voluson P6 And Voluson P8 |
| 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 | 2018-02-28 |
| Decision Date | 2018-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682138208 | K180535 | 000 |
| 00840682138192 | K180535 | 000 |
| 00195278473103 | K180535 | 000 |
| 00195278473097 | K180535 | 000 |
| 00195278473011 | K180535 | 000 |