BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    CARESCAPE B450

    K Number: K191249 · Decision Jan 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    30
    Review Days
    260

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    Basic Information

    Device Name
    CARESCAPE B450
    K Number
    K191249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Healthcare Finland Oy
    Date Received
    May 9, 2019
    Decision Date
    January 24, 2020
    Product Code
    MHX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by GE Healthcare Finland Oy

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    K213336 Carescape B850, E-musb
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    K191322 E-EEGX, N-EEGX
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