FDA-Device2014-05-21Class II
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS
Mindray DS USA, Inc. dba Mindray North America
Hazard
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Sold states
US Nationwide Distribution in the state of OH
Affected count
4 units
Manufactured in
800 MacArthur Blvd, Mahwah, NJ, United States
Products
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2014Don't want to check this manually?
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