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

    MODEL 6000 TWO PARAMETER BEDSIDE MONITOR

    K Number: K091787 · Decision Oct 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    27
    Review Days
    114

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    Basic Information

    Device Name
    MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
    K Number
    K091787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ivy Biomedical Systems, Inc.
    Date Received
    June 17, 2009
    Decision Date
    October 9, 2009
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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