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

    CelerityTM 10 STEAM Chemical Indicator

    K Number: K182724 · Decision Dec 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    262
    Applicant Total
    169
    Review Days
    73

    Basic Information

    Device Name
    CelerityTM 10 STEAM Chemical Indicator
    K Number
    K182724
    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 Corporation
    Date Received
    September 28, 2018
    Decision Date
    December 10, 2018
    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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