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

    ICON, MODEL C3

    K Number: K082242 · Decision Oct 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    113
    Applicant Total
    7
    Review Days
    62

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    Basic Information

    Device Name
    ICON, MODEL C3
    K Number
    K082242
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osypka Medical, Inc.
    Date Received
    August 7, 2008
    Decision Date
    October 8, 2008
    Product Code
    DSB
    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
    DSB Plethysmograph, Impedance

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