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

    CARDISUNY 501BIII

    K Number: K901948 · Decision Jul 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    8
    Review Days
    78

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    Basic Information

    Device Name
    CARDISUNY 501BIII
    K Number
    K901948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Graham-Field, Inc.
    Date Received
    April 30, 1990
    Decision Date
    July 17, 1990
    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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