510(k) K101571 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
| Applicant | Witt Biomedical Corp, Melbourne FL, US |
| Decision | Substantially Equivalent, Oct 26, 2010 |
| Received | Jun 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2021 | Philips North America Llc Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring
Service n Open, Classified |
MWI | None listed |
| Nov 15, 2018 | Philips Electronics North America Corporation Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 Terminated |
DQK | None listed |
| Sep 24, 2018 | Invivo Corporation Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 Completed |
DQK | None listed |
| Aug 3, 2018 | Invivo Corporation Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 Terminated |
MWI | None listed |
| Nov 20, 2017 | Invivo Corporation Xper Flex Cardio Physiomonitoring System
The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant Open, Classified |
MWI | None listed |
| Aug 18, 2017 | Invivo Corporation Xper Flex Cardio Physiomonitoring system.
Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such. Terminated |
MWI | None listed |
| Aug 11, 2017 | Invivo Corporation Xper Flex Cardio PhysioMonitoring system
The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant Terminated |
MWI | None listed |
| Oct 19, 2015 | Invivo Corporation The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device. Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.