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 |