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

    DATASCOPE MODEL VISA CENTRAL MONITOR

    K Number: K913576 · Decision Jan 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    9
    Review Days
    169

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    Basic Information

    Device Name
    DATASCOPE MODEL VISA CENTRAL MONITOR
    K Number
    K913576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Accucore, Inc.
    Date Received
    August 12, 1991
    Decision Date
    January 28, 1992
    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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