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

    DIGITAL AMBULATORY ECG (HOLTER) RECORDER

    K Number: K031074 · Decision Oct 15, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    5
    Review Days
    194

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    Basic Information

    Device Name
    DIGITAL AMBULATORY ECG (HOLTER) RECORDER
    K Number
    K031074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datrix
    Date Received
    April 4, 2003
    Decision Date
    October 15, 2003
    Product Code
    MWJ
    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
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

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