BEUDAMED
    Product Code: SIB FDA not classified

    Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic

    Unknown
    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    SIB
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    CH
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    TEMPO Pilot: early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes)

    Unclassified Reason

    6