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

    HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER

    K Number: K121770 · Decision Apr 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    306

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    Basic Information

    Device Name
    HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
    K Number
    K121770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Headstar Medical Products Co., Ltd.
    Date Received
    June 15, 2012
    Decision Date
    April 17, 2013
    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 Headstar Medical Products Co., Ltd.

    K Number Device Name
    K002846 HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR