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

    STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR

    K Number: K141580 · Decision Dec 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    10
    Review Days
    187

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    Basic Information

    Device Name
    STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
    K Number
    K141580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tso3, Inc.
    Date Received
    June 13, 2014
    Decision Date
    December 17, 2014
    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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    K141698 STERIZONE CHEMICAL INDICATOR
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