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

    HERO, VERSION 2.0

    K Number: K081473 · Decision Jun 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    570
    Applicant Total
    2
    Review Days
    31

    Basic Information

    Device Name
    HERO, VERSION 2.0
    K Number
    K081473
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDICAL PREDICTIVE SCIENCE CORP.
    Date Received
    May 27, 2008
    Decision Date
    June 27, 2008
    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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