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510(k) Data Aggregation

    K Number
    K040574
    Device Name
    GALILEO GOLD
    Manufacturer
    HAMILTON MEDICAL, INC.
    Date Cleared
    2004-10-27

    (237 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galileo Gold ventilator is intended to provide positive pressure ventilatory support to Adults, Pediatrics and Infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside or for intra-facility transport, provided compressed gas is supplied. The device is not intended for transport, outside the hospital or for use in the home environment.
    Device Description
    The Galileo ventilator is a legally marketed intensive care ventilator (K982910, K001686). The four modifications included in this application are purely software-related and do not change the hardware of the Galleo Gold ventilator. This application is for the following options to the Galileo Gold ventilator: DuoPAP and APRV modes, NIV mode, MMV+ mode, and TRC feature.
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    K Number
    K001686
    Device Name
    GALILEO VENTILATOR
    Manufacturer
    HAMILTON MEDICAL, INC.
    Date Cleared
    2000-06-23

    (36 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982910
    Device Name
    HAMILTON MEDICAL GALILEOVENTILATOR
    Manufacturer
    HAMILTON MEDICAL, INC.
    Date Cleared
    1999-09-14

    (392 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galileo Ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients. The Galileo ventilator is intended for use where patient care is provided in the hospital and institutional environment. It is not intended for transport outside by health care professional environment or for home use.
    Device Description
    Not Found
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    K Number
    K990293
    Device Name
    ALADDIN II MONITORING OXYGEN/AIR MONITOR
    Manufacturer
    HAMILTON MEDICAL, INC.
    Date Cleared
    1999-03-16

    (46 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.
    Device Description
    Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM).
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    K Number
    K960359
    Device Name
    ALADDIN MONITORING OXYGEN/AIR MIXER
    Manufacturer
    HAMILTON MEDICAL, INC.
    Date Cleared
    1996-04-24

    (90 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON MEDICAL, INC.

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

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