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

    AllPEP

    K Number: K233855 · Decision Feb 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    2
    Review Days
    59

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    Basic Information

    Device Name
    AllPEP
    K Number
    K233855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Enchant Tek Co. , Ltd.
    Date Received
    December 5, 2023
    Decision Date
    February 2, 2024
    Product Code
    BWF
    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
    BWF Spirometer, Therapeutic (Incentive)

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    Other Clearances by Enchant Tek Co. , Ltd.

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