510(k) K050093 ยท DQK Computer, Diagnostic, Programmable
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, May 13, 2005 |
| Received | Jan 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050093
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2024 | GE Medical Systems Information Technologies Inc Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare Open, Classified |
DQK | None listed |
| Aug 7, 2007 | General Electric Medical Systems Information Technology GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwauk Terminated |
DQK | None listed |
| Aug 7, 2007 | General Electric Medical Systems Information Technology GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, Terminated |
DQK | None listed |
| Aug 7, 2007 | General Electric Medical Systems Information Technology GE Healthcare Systems ComboLab System. Made up of both
Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiolog Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.