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510(k) Data Aggregation

    K Number
    K993199
    Device Name
    POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
    Manufacturer
    FERRARIS MEDICAL, INC.
    Date Cleared
    2000-03-28

    (187 days)

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

    FERRARIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
    Device Description
    The Pocket Chamber Valved Aerosol Holding Chamber is a cylindrical tube, approximately 3.1 inches long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent offcenter actuations. A one-way valve is located at the juncture between the mouthpiece and the body.
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    K Number
    K992038
    Device Name
    POCKETSPACER
    Manufacturer
    FERRARIS MEDICAL, INC.
    Date Cleared
    1999-09-09

    (85 days)

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

    FERRARIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PocketSpacer is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
    Device Description
    The PocketSpacer is a cylindrical tube, approximately 10 cm long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent off-center actuations. An open mesh with varying size circular orifices, but no valve, is in the round mouthpiece. The mesh with concentrically placed circular orifices removes the throat dose by permitting only respirable particles to be inhaled by the user.
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