BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Filter and HME/Filter

    K Number: K221472 · Decision Feb 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    199
    Applicant Total
    1
    Review Days
    264

    Basic Information

    Device Name
    Filter and HME/Filter
    K Number
    K221472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ningbo Huakun Medical Equipment Co., Ltd.
    Date Received
    May 20, 2022
    Decision Date
    February 8, 2023
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    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
    CAH Filter, Bacterial, Breathing-Circuit

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