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

    STERRAD VELOCITY Biological Indicator

    K Number: K182404 · Decision Dec 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    114

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    Basic Information

    Device Name
    STERRAD VELOCITY Biological Indicator
    K Number
    K182404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Sterilization Products (Asp)
    Date Received
    September 4, 2018
    Decision Date
    December 27, 2018
    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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    Other Clearances by Advanced Sterilization Products (Asp)

    K Number Device Name
    K192025 STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
    K181472 AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
    K170039 STERRAD VELOCITY Biological Indictator and Reader
    K152189 EVOTECH ECR