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

    SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM

    K Number: K955743 · Decision Jul 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    395
    Applicant Total
    519
    Review Days
    203

    Basic Information

    Device Name
    SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
    K Number
    K955743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Received
    December 18, 1995
    Decision Date
    July 8, 1996
    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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