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

    CapKlenZ

    K Number: K192382 · Decision Apr 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    234

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    Basic Information

    Device Name
    CapKlenZ
    K Number
    K192382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Star Mountain Medical, Inc.
    Date Received
    August 30, 2019
    Decision Date
    April 20, 2020
    Product Code
    QBP
    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
    QBP Cap, Device Disinfectant

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