BEUDAMED
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    Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,

    FDA Enforcement
    Class II ·Terminated·Stellate Systems·May 1, 2013

    DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE DP SB CONTOUR LOWER LEG WITH MATCHING LIMB PROTECTION SLEEVE

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Delfi Medical Innovations Inc.·1 device

    DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE SP SB CONTOUR LOWER LEG WITH MATCHING LIMB PROTECTION SLEEVE

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Delfi Medical Innovations Inc.·1 device