510(k) K082421 ยท DQK Computer, Diagnostic, Programmable
HEARTSUITE HEMODYNAMICS 7.10
| Applicant | Emageon, Inc., Hartland WI, US |
| Decision | Substantially Equivalent, Dec 17, 2008 |
| Received | Aug 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2017 | Merge Healthcare, Inc. Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a Terminated |
DQK | None listed |
| Apr 11, 2017 | Merge Healthcare, Inc. Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheteriza Terminated |
DQK | None listed |
| Aug 4, 2016 | Merge Healthcare, Inc. Merge HEMO software. Terminated |
DQK | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge Hemo software.
Product Usage:
Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. Terminated |
DQK | None listed |
| Mar 28, 2016 | Merge Healthcare, Inc. Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure Terminated |
DQK | None listed |
| Mar 10, 2016 | Merge Healthcare, Inc. The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software. Terminated |
DQK | None listed |
| Oct 26, 2015 | Merge Healthcare, Inc. Merge Hemo with software versions 10.0 LA.
Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterizati Terminated |
DQK | None listed |
| Aug 6, 2015 | Merge Healthcare, Inc. Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and r Terminated |
DQK | None listed |
| May 31, 2015 | Merge Healthcare, Inc. The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software. Terminated |
DQK | None listed |
| Oct 28, 2014 | Merge Healthcare, Inc. Merge Healthcare, Merge Hemo Programmable diagnostic computer.
The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial Terminated |
DQK | None listed |
| Apr 30, 2014 | Merge Healthcare, Inc. Merge Hemo software.
Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.