The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Cardiq Function Xpress.
| Device ID | K073153 |
| 510k Number | K073153 |
| Device Name: | CARDIQ FUNCTION XPRESS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE BP 34 Buc Cedex, FR 78533 |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-08 |
| Decision Date | 2008-02-26 |
| Summary: | summary |