BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 27, 2013

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021