BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    E3-80 PORTABLE ECG RECORDER & ANALYZER

    K Number: K071085 · Decision Oct 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    169

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    Basic Information

    Device Name
    E3-80 PORTABLE ECG RECORDER & ANALYZER
    K Number
    K071085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Star International Co., Ltd.
    Date Received
    April 17, 2007
    Decision Date
    October 3, 2007
    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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