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

    MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR

    K Number: K133753 · Decision Sep 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    5
    Review Days
    284

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    Basic Information

    Device Name
    MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
    K Number
    K133753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infobionic, Inc.
    Date Received
    December 9, 2013
    Decision Date
    September 19, 2014
    Product Code
    QYX
    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
    QYX Outpatient Cardiac Telemetry

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    Other Clearances by Infobionic, Inc.

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