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

    FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX

    K Number: K000746 · Decision Apr 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    395
    Applicant Total
    66
    Review Days
    30

    Basic Information

    Device Name
    FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
    K Number
    K000746
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FUKUDA DENSHI USA, INC.
    Date Received
    March 8, 2000
    Decision Date
    April 7, 2000
    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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