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

    ER800 SERIES ECG EVENT RECORDER

    K Number: K030856 · Decision Mar 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    5
    Review Days
    10

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    Basic Information

    Device Name
    ER800 SERIES ECG EVENT RECORDER
    K Number
    K030856
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Braemar Corp.
    Date Received
    March 18, 2003
    Decision Date
    March 28, 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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