BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Zener® (model ZEN-001-B1)

    K Number: K252128 · Decision Sep 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    70

    Basic Information

    Device Name
    Zener® (model ZEN-001-B1)
    K Number
    K252128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uvx, Inc.
    Date Received
    July 7, 2025
    Decision Date
    September 15, 2025
    Product Code
    FRA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FRA Purifier, Air, Ultraviolet, Medical

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