The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Card Ep.
| Device ID | K031261 |
| 510k Number | K031261 |
| Device Name: | CARD EP |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS P.O. 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Heinz Joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-04-21 |
| Decision Date | 2003-05-06 |
| Summary: | summary |