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

    Instant 20s Indicator

    K Number: K210481 · Decision Dec 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    298

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    Basic Information

    Device Name
    Instant 20s Indicator
    K Number
    K210481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    True Indicating, LLC
    Date Received
    February 19, 2021
    Decision Date
    December 14, 2021
    Product Code
    MTC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MTC Indicator, Chemical, Enzymatic, Sterilization Process

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