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510(k) Data Aggregation

    K Number
    K112041
    Device Name
    KOO SMALL VOLUME NEBULIZER (SVN)
    Date Cleared
    2011-12-22

    (157 days)

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

    KOO(SHANGHAI)INDUSTRIES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Koo SVN is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. The Koo SVN is intended for use with pediatric (defined by the prescribed medication) and adult patients consistent with the indications for the aerosol medication. This includes hospital/institutional settings, home care use, schools and long term care facilities.
    Device Description
    The Koo SVN is a simple handheld small volume nebulizer powered by compressed air to nebulize the I ne Noo S V It is a simple handler shall vith a mouthpiece or standard aerosol / oxygen face mask. The SVN can be packaged with optional accessories, i.e., oxygen tubing, mouthpiece and hose, and face mask. The nebulizer and its accessories are single patient, multi-use devices.
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    K Number
    K101136
    Device Name
    FISIO CHAMBER SPACE
    Date Cleared
    2011-01-28

    (281 days)

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

    KOO(SHANGHAI)INDUSTRIES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fisio Chamber Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional. Environments of use - Home care, nursing homes, sub-acute institutions, and hospitals
    Device Description
    The Fisio Chamber Spacer is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a translucent housing and mouth piece or face mask and a one-way valve to prevent exhaling into the chamber. The Fisio Chamber Spacer is intended to be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances: - · Corticosteroids (anti-inflammatory medications) - · Anti-cholinergics and B2-sympathomimetics (bronchodilater medications) - · Non-steroidal chromones (DNCG) It is a single patient, multi-use non-sterile device.
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