FDA-Device2018-06-13Class II
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 cur
Invivo Corporation
Hazard
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Sold states
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.
Affected count
1,040 units (USA) and 7 units (Foreign)
Manufactured in
12151 Research Pkwy Ste 200, N/A, Orlando, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2018Don't want to check this manually?
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