BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    AllNEB

    K Number: K242354 · Decision Apr 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    188
    Same Product Code
    503
    Applicant Total
    2
    Review Days
    264

    Basic Information

    Device Name
    AllNEB
    K Number
    K242354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Enchant Tek Co. Ltd.
    Date Received
    August 8, 2024
    Decision Date
    April 29, 2025
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Enchant Tek Co. Ltd.

    K Number Device Name
    K233855 AllPEP