The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Integrated Innova - S5i System Option.
| Device ID | K111209 |
| 510k Number | K111209 |
| Device Name: | INTEGRATED INNOVA - S5I SYSTEM OPTION |
| Classification | System, X-ray, Angiographic |
| Applicant | GE HEALTHCARE 283, RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Faycal Kherra |
| Correspondent | Faycal Kherra GE HEALTHCARE 283, RUE DE LA MINIERE Buc, FR 78530 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-29 |
| Decision Date | 2011-07-26 |
| Summary: | summary |