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510(k) Data Aggregation

    K Number
    K012446
    Device Name
    OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
    Manufacturer
    CHARLES A. SMITH
    Date Cleared
    2001-10-03

    (63 days)

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

    CHARLES A. SMITH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Office Based Anesthesia Unit - OBA-1™ MRI is intended for administration of general inhalation anesthesia using mixtures of volatile anesthetics, and for providing breathing gas and for either spontaneous ventilation or controlled ventilation of patient lungs. The OBA-1™ MRI can be used in MRI scanner rooms with shielded or unshielded magnets up to 1.5 tesla.
    Device Description
    The OBA-1™ MRI is an anesthesia unit which includes these features: Can be connected to a central pipeline or cylinder oxygen/air source. Oxygen flowmeter 0 10 L/min. Air flowmeter 0 10 L/min. Oxygen and air pipeline pressure gauges 0 100 psi. Oxygen Supply Failure Alarm. Vaporizer temperature and pressure compensated. Oxygen Flush valve. Back Pressure Check valve. Indexed Fresh Gas Common outlet with safety lock. Patient Manifold with directional valves inspiratory and expiratory. Adjustable APL valve with 19 mm waste gas outlet connection which can be connected to an active scavenging system. MRI compatible Airway Pressure Gauge. Oxygen sensor port. Circuit Pressure monitor and gauge connection ports. THERMH2OSORB Sodalime CO2 absorber. Bag/Ventilator Switch Valve 22 mm breathing bag port and 22 mm ventilator hose port.
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    K Number
    K000859
    Device Name
    OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
    Manufacturer
    CHARLES A. SMITH
    Date Cleared
    2000-08-23

    (159 days)

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

    CHARLES A. SMITH

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

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