BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HSINER JET NEBULIZER, MODEL HS-31100

    K Number: K052811 · Decision Dec 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    188
    Same Product Code
    503
    Applicant Total
    6
    Review Days
    78

    Basic Information

    Device Name
    HSINER JET NEBULIZER, MODEL HS-31100
    K Number
    K052811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HSINER CO., LTD.
    Date Received
    October 4, 2005
    Decision Date
    December 21, 2005
    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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