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

    Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S

    K Number: K082173 · Decision Aug 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    10
    Review Days
    25

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    Basic Information

    Device Name
    Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
    K Number
    K082173
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiac Science Corporation
    Date Received
    August 1, 2008
    Decision Date
    August 26, 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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