BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    myMerlin(TM) Mobile Application Model APP1001

    K Number: K173232 · Decision Nov 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    105
    Review Days
    29

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    Basic Information

    Device Name
    myMerlin(TM) Mobile Application Model APP1001
    K Number
    K173232
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    St Jude Medical
    Date Received
    October 4, 2017
    Decision Date
    November 2, 2017
    Product Code
    MXC
    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
    MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

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