The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson S6, Voluson S8, Voluson S10.
| Device ID | K160184 |
| 510k Number | K160184 |
| Device Name: | Voluson S6, Voluson S8, Voluson S10 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE HEALTHCARE 9900 W. INNOVATION DRIVE Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz 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 | 2016-01-27 |
| Decision Date | 2016-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682111416 | K160184 | 000 |
| 00840682104241 | K160184 | 000 |
| 00840682104319 | K160184 | 000 |
| 00840682104876 | K160184 | 000 |
| 00840682106962 | K160184 | 000 |
| 00840682108256 | K160184 | 000 |
| 00840682110006 | K160184 | 000 |
| 00840682110860 | K160184 | 000 |
| 00840682110952 | K160184 | 000 |
| 00840682104234 | K160184 | 000 |