XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS— 510(k) K101571
Substantially EquivalentWitt Biomedical Corp
FDA 510(k) clearance K101571 for XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS, Substantially Equivalent on 2010-10-26. Applicant: Witt Biomedical Corp. Device class: 2.
Clearance details
- Applicant
- Witt Biomedical Corp
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melbourne, FL, US
Recent devices under product code MWI
view allMore clearances from Witt Biomedical Corp
view all- K063840 — XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION
- K063547 — CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
- K040195 — CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM
- K033030 — CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101571
K-number listed on FDA's recall record- Z-1517-2021 — 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 numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010 Rev B 453564483321 Flex Cardio FC2010 Rev C 453564621791 Xper Flex Cardio 2010 REV C RUEXCHANGE 453564675021 Xper Flex Cardio 2010 Rev D 453564669081 Xper Flex Cardio 2010 Rev D Russia 453564674581 Xper Flex Cardio FC2010 Rev E 453564845841 Xper Flex Cardio 2010 Rev E Russia 453564845881 Service numbers associated with FC2020: Xper Flex Cardio 2020 Rev A 453564241911 Xper Flex Cardio 2020 Rev B 453564483331 Flex Cardio FC2020 Rev C 453564621801 Xper Flex Cardio 2020 Rev D 453564675001 Xper Flex Cardio FC2020 Rev E 453564845861 Software version number: 1.5.19 and 1.6.8
- Z-0614-2019 — 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
- Z-0462-2019 — Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
- Z-3192-2018 — Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
- Z-2115-2018 — 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 such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.
- Z-0263-2018 — Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
- Z-0082-2018 — 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 such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.
- Z-2760-2016 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101571.
Data sourced from openFDA. This site is unofficial and independent of the FDA.