The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Cardiq Xpress 2.0 With Snapshot Freeze Option Cardiq Xpress 2.0 Reveal.
| Device ID | K120910 |
| 510k Number | K120910 |
| Device Name: | CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS SCS 283, RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Stephen Slavens |
| Correspondent | Stephen Slavens GE MEDICAL SYSTEMS SCS 283, RUE DE LA MINIERE Buc, FR 78530 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-26 |
| Decision Date | 2012-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682142601 | K120910 | 000 |