The following data is part of a premarket notification filed by Gef Medical Systems Scs with the FDA for Faststroke.
| Device ID | K163281 |
| 510k Number | K163281 |
| Device Name: | FastStroke |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GEf Medical Systems SCS 283 Rue De La Miniere Buc, FR 78530 |
| Contact | Kristine Schraufnagel |
| Correspondent | Kristine Schraufnagel GEf Medical Systems SCS 283 Rue De La Miniere Buc, FR 78530 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-01-26 |
| Summary: | summary |