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

    PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR

    K Number: K994381 · Decision Mar 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    15
    Review Days
    458

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    Basic Information

    Device Name
    PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
    K Number
    K994381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Raven Biological Laboratories, Inc.
    Date Received
    December 28, 1999
    Decision Date
    March 30, 2001
    Product Code
    FRC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Expedited Review
    Y
    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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