The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Cardiq Flow.
| Device ID | K192277 |
| 510k Number | K192277 |
| Device Name: | CardIQ Flow |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE Medical Systems SCS 283 Rue De La Miniere Buc, FR 78530 |
| Contact | Elizabeth Mathew |
| Correspondent | Elizabeth Mathew GE Medical Systems SCS 283 Rue De La Miniere Buc, FR 78530 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2020-02-14 |