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

    MERITS MODEL N SERIES NEBULIZER COMPRESSORS

    K Number: K092859 · Decision Jul 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    19
    Review Days
    288

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    Basic Information

    Device Name
    MERITS MODEL N SERIES NEBULIZER COMPRESSORS
    K Number
    K092859
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merits Health Products Co., Ltd.
    Date Received
    September 17, 2009
    Decision Date
    July 2, 2010
    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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