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

    APEX MEDICAL MOBINEB, 9R-027 SERIES

    K Number: K070990 · Decision May 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    30
    Review Days
    39

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    Basic Information

    Device Name
    APEX MEDICAL MOBINEB, 9R-027 SERIES
    K Number
    K070990
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apex Medical Corp.
    Date Received
    April 9, 2007
    Decision Date
    May 18, 2007
    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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