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    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    AirKEE T900

    K Number: K232642 · Decision May 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    267

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    Basic Information

    Device Name
    AirKEE T900
    K Number
    K232642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healkee Medical Pte, Ltd.
    Date Received
    August 30, 2023
    Decision Date
    May 23, 2024
    Product Code
    FRA
    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
    FRA Purifier, Air, Ultraviolet, Medical

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    Other Clearances by Healkee Medical Pte, Ltd.

    K Number Device Name
    K232933 AirKEE P900