BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Cardio-TriTest v6.5

    K Number: K182790 · Decision Dec 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    Cardio-TriTest v6.5
    K Number
    K182790
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardio-Phoenix, Inc.
    Date Received
    October 1, 2018
    Decision Date
    December 14, 2018
    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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    Other Clearances by Cardio-Phoenix, Inc.

    K Number Device Name
    K143432 Cardio-TriTest