The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies Gmbh with the FDA for Case Cardiac Testing System, Cs Cardiac Testing System.
| Device ID | K103678 |
| 510k Number | K103678 |
| Device Name: | CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH MUNZINGER STRASSE 5 Freiburg,baden Wurttemberg, DE 79111 |
| Contact | Albrecht Malkmus |
| Correspondent | Albrecht Malkmus GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH MUNZINGER STRASSE 5 Freiburg,baden Wurttemberg, DE 79111 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-16 |
| Decision Date | 2011-02-16 |
| Summary: | summary |