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

    BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set

    K Number: K171514 · Decision Jun 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    28
    Applicant Total
    6
    Review Days
    36

    Basic Information

    Device Name
    BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
    K Number
    K171514
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIOTRONIK, Inc.
    Date Received
    May 24, 2017
    Decision Date
    June 29, 2017
    Product Code
    MXD
    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
    MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

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