BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ACG-8511 PORTABLE ECG MONITOR

    K Number: K110328 · Decision Jul 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    92
    Review Days
    162

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    Basic Information

    Device Name
    ACG-8511 PORTABLE ECG MONITOR
    K Number
    K110328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Andon Health Co, Ltd.
    Date Received
    February 3, 2011
    Decision Date
    July 15, 2011
    Product Code
    DPS
    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
    DPS Electrocardiograph

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