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

    VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM

    K Number: K213412 · Decision Jan 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    2
    Review Days
    94

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    Basic Information

    Device Name
    VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
    K Number
    K213412
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Steris Corparation
    Date Received
    October 19, 2021
    Decision Date
    January 21, 2022
    Product Code
    JOJ
    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
    JOJ Indicator, Physical/Chemical Sterilization Process

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