BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT

    K Number: K082539 · Decision Dec 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
    K Number
    K082539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health Germany 234 GmbH
    Date Received
    September 2, 2008
    Decision Date
    December 2, 2008
    Product Code
    BTY
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTY Calculator, Predicted Values, Pulmonary Function

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