510(k) K050561 ยท DQK Computer, Diagnostic, Programmable
WINDSURFER
| Applicant | Medcon , Ltd., Efrat, IL |
| Decision | Substantially Equivalent, May 4, 2005 |
| Received | Mar 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050561
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2024 | CHANGE HEALTHCARE CANADA COMPANY Horizon Cardiology Hemo. Version 12.2. Open, Classified |
DQK | None listed |
| Jul 9, 2010 | McKesson Provider Technologies - Medical Imaging Group Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit.
Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M.
A programmable diagnostic computer intended for acquiring, di Terminated |
DQK | None listed |
| Jun 24, 2010 | McKesson Provider Technologies - Medical Imaging Group Horizon Cardiology Hemo Monitoring System
A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac cather Terminated |
DQK | None listed |
| Feb 5, 2008 | McKesson Provider Technologies Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC
50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel. Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.