BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ENSEMBLE CENTRAL STATION MONITOR

    K Number: K970358 · Decision Feb 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    34
    Review Days
    377

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    Basic Information

    Device Name
    ENSEMBLE CENTRAL STATION MONITOR
    K Number
    K970358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mennen Medical, Inc.
    Date Received
    January 30, 1997
    Decision Date
    February 11, 1998
    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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