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

    MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES

    K Number: K073462 · Decision Jan 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    411
    Applicant Total
    136
    Review Days
    32

    Basic Information

    Device Name
    MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
    K Number
    K073462
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Date Received
    December 10, 2007
    Decision Date
    January 11, 2008
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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