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

    BIOSIGN STEAM-24 BIOLOGICAL INDICATOR

    K Number: K032723 · Decision Oct 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    4
    Review Days
    28

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    Basic Information

    Device Name
    BIOSIGN STEAM-24 BIOLOGICAL INDICATOR
    K Number
    K032723
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Getinge USA, Inc.
    Date Received
    September 3, 2003
    Decision Date
    October 1, 2003
    Product Code
    FRC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRC Indicator, Biological Sterilization Process

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