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

    MIDA SYSTEM, MODELS 1000/1100

    K Number: K896396 · Decision Jan 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    23
    Review Days
    73

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    Basic Information

    Device Name
    MIDA SYSTEM, MODELS 1000/1100
    K Number
    K896396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical Graphics Corp.
    Date Received
    November 6, 1989
    Decision Date
    January 18, 1990
    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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