The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Cardiosoft/case Cardiac Testing System.
| Device ID | K031561 |
| 510k Number | K031561 |
| Device Name: | CARDIOSOFT/CASE CARDIAC TESTING SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | David Wahlig |
| Correspondent | David Wahlig GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-08-01 |
| Summary: | summary |