BEUDAMED
    2 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Inc Mortara·April 28, 2021

    ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Inc Mortara·April 28, 2021