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

    DISPOSABLE NEBULIZER SET

    K Number: K140237 · Decision Jan 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    343

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    Basic Information

    Device Name
    DISPOSABLE NEBULIZER SET
    K Number
    K140237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Weikang Medical Apparatus Co., Ltd.
    Date Received
    January 30, 2014
    Decision Date
    January 8, 2015
    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 Suzhou Weikang Medical Apparatus Co., Ltd.

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