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

    Faros Mobile

    K Number: K182030 · Decision Nov 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    101

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    Basic Information

    Device Name
    Faros Mobile
    K Number
    K182030
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bittium Biosignals , Ltd.
    Date Received
    July 30, 2018
    Decision Date
    November 8, 2018
    Product Code
    MLO
    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
    MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

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