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510(k) Data Aggregation

    K Number
    K963349
    Device Name
    DEVILBISS 8650D
    Manufacturer
    DEVILBISS HEALTH CARE, INC.
    Date Cleared
    1997-06-13

    (291 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEVILBISS HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 8650D will be used as the air source to nebulize sterile water to provide humidification to patients with tracheostomies. The 8650Dxmay also be used to nebulize medications in the treatment of Asthma, Cystic Fibrosis, and chronic obstructive pulmonary disease.
    Device Description
    The DeVilbiss 8650D Compressor is a portable AC powered air compressor that will act as an air source to operate a pneumatic nebulizer. The device has an internal cooling fan to allow continuous use operation. It uses a metal housing with sound barrier foam to provide a low noise level.
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    K Number
    K970289
    Device Name
    COMPRESSOR/NEBULIZER #3650
    Manufacturer
    DEVILBISS HEALTH CARE, INC.
    Date Cleared
    1997-04-15

    (81 days)

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

    DEVILBISS HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease.
    Device Description
    The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. In terms of function, safety and effectiveness this device is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431, Attachment D). Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3650 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E). This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 6.0 & 7.0).
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    K Number
    K961126
    Device Name
    PULSE DOSE SERIES
    Manufacturer
    DEVILBISS HEALTH CARE, INC.
    Date Cleared
    1996-10-21

    (214 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEVILBISS HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Pulse Dose Series devices are fundamentally repackaged versions of the OMS 20 and 50, DeVilbiss' current Oxygen Management Systems. The devices provide a bolus of oxygen to a patient at the start of inhalation. The devices assist patients, who require prescribed doses of supplemental gases such as oxygen, to conserve gas from the various gaseous cylinders or liguid oxygen reservoirs. By allowing oxygen to flow only from the cylinder or liquid oxygen reservoirs during the inspiratory segment of a patient's breathing cycle, conservation occurs.
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    K Number
    K950849
    Device Name
    MODEL #7354
    Manufacturer
    DEVILBISS HEALTH CARE, INC.
    Date Cleared
    1996-02-08

    (349 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEVILBISS HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952491
    Device Name
    MODEL 7355
    Manufacturer
    DEVILBISS HEALTH CARE, INC.
    Date Cleared
    1996-01-31

    (246 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEVILBISS HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952249
    Device Name
    JET NEBULIZER
    Manufacturer
    DEVILBISS HEALTH CARE, INC.
    Date Cleared
    1996-01-30

    (260 days)

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

    DEVILBISS HEALTH CARE, INC.

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