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

    Zuno Smart Sterilization Container

    K Number: DEN210004 · Decision Jun 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    486

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    Basic Information

    Device Name
    Zuno Smart Sterilization Container
    K Number
    DEN210004
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.6855
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Zuno Medical, Inc.
    Date Received
    February 16, 2021
    Decision Date
    June 17, 2022
    Product Code
    QJT
    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
    QJT Rigid Sterilization Container With Software