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510(k) Data Aggregation

    K Number
    K121770
    Device Name
    HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
    Manufacturer
    HEADSTAR MEDICAL PRODUCTS CO., LTD
    Date Cleared
    2013-04-17

    (306 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEADSTAR MEDICAL PRODUCTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Headstar medical Small Volume Jet nebulizer creates respiratory mist out of the drug and is used to administer various aerosol treatments to adult and pediatric patients in homecare and hospital environments. It is not intended for transport use. Based on practical measurement and comparison, Headstar Medical Small Volume Jet Nebulizer is intended for following populations: HP-2557 Nebulizer with child face mask: 2~9 years old pediatric patients HP-2558 Nebulizer with adult face mask: for adult patients HP-2290 Nebulizer with mouth piece & O2 tubing: pediatric over 5 years and adult patients HP-2291 Nebulizer with mouth/T piece & hose/O2 tubing: pediatric over 5 years and adult patients The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It can be packaged with optional accessories; i.e .; oxygen tubing, mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.
    Device Description
    The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It can be packaged with optional accessories; i.e .; oxygen tubing, mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.
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    K Number
    K002846
    Device Name
    HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
    Manufacturer
    HEADSTAR MEDICAL PRODUCTS CO., LTD
    Date Cleared
    2001-06-06

    (267 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEADSTAR MEDICAL PRODUCTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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