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510(k) Data Aggregation

    K Number
    K072420
    Device Name
    MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
    Manufacturer
    OCEANIC MEDICAL PRODUCTS, INC.
    Date Cleared
    2008-01-22

    (147 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCEANIC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Magellan-2200, Model-3 Anesthesia Machine is intended/indicated for spontaneous or manually assisted ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and source oxygen pressure.
    Device Description
    The Model-3 is a gas machine for anesthesia or analgesia. The device consists of the following components: an inlet gas manifold for oxygen and air; pressure gauges for oxygen and air; a low-pressure alarm for inlet oxygen surveillance; an oxygen analyzer and monitor; an oxygen flow selector for nasal cannula or oxygen mask for pre- and post-anesthesia use; an oxygen flush button; oxygen and air flowmeters; an agent-specific vaporizer; a common gas outlet; a carbon dioxide absorber with one way valves; and a reservoir bag/pressure gauge/pressure relief/scavenger outlet arm.
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    K Number
    K060193
    Device Name
    MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
    Manufacturer
    OCEANIC MEDICAL PRODUCTS, INC.
    Date Cleared
    2006-04-10

    (75 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCEANIC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Magellan-2200 Model-2 Anesthesia Machine is intended for spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes. The Magellan-2200 Model-2 Anesthesia Machine in indicated for use with spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.
    Device Description
    The Magellan-2200 Model-2 consists of the following components: Gas Manifold with Safety Connections Low Pressure Oxygen Alarm Oxygen and Air Pressure Gauges Oxygen Auxiliary Flow Selector Oxygen and Air Flowmeters
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    K Number
    K010613
    Device Name
    MAGELLAN-2200, MODEL 1
    Manufacturer
    OCEANIC MEDICAL PRODUCTS, INC.
    Date Cleared
    2001-10-12

    (225 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCEANIC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002951
    Device Name
    MAGELLAN VENTILATOR
    Manufacturer
    OCEANIC MEDICAL PRODUCTS, INC.
    Date Cleared
    2000-12-08

    (78 days)

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

    OCEANIC MEDICAL PRODUCTS, INC.

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

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