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

    FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON

    K Number: K853213 · Decision Oct 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    68
    Review Days
    144

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    Basic Information

    Device Name
    FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
    K Number
    K853213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Fukuda Denshi USA, Inc.
    Date Received
    May 20, 1985
    Decision Date
    October 11, 1985
    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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