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

    AirKEE P900

    K Number: K232933 · Decision May 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    239

    Basic Information

    Device Name
    AirKEE P900
    K Number
    K232933
    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
    September 20, 2023
    Decision Date
    May 16, 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
    K232642 AirKEE T900