BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    MIDA ALGORITHM REV. B

    K Number: K023414 · Decision Dec 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    420

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    Basic Information

    Device Name
    MIDA ALGORITHM REV. B
    K Number
    K023414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortivus AB
    Date Received
    October 11, 2002
    Decision Date
    December 5, 2003
    Product Code
    DYC
    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
    DYC Vectorcardiograph

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