BEUDAMED
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    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.

    FDA Recall
    Terminated ·Circadiance LLC·Product code NPE·May 1, 2017

    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.

    FDA Enforcement
    Class II ·Terminated·Circadiance LLC·June 14, 2017