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

    IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS

    K Number: K830163 · Decision Feb 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    8
    Review Days
    31

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    Basic Information

    Device Name
    IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS
    K Number
    K830163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Intl. Business Machines
    Date Received
    January 18, 1983
    Decision Date
    February 18, 1983
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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