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510(k) Data Aggregation

    K Number
    K193250
    Device Name
    Irrigation Tubing with CO2 or Air
    Manufacturer
    KeyMed (Medical and Industrial Equipment) Ltd.
    Date Cleared
    2020-04-06

    (133 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    KeyMed (Medical and Industrial Equipment) Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
    Device Description
    The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.
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    K Number
    K971030
    Device Name
    MIE FALCON, DATEX ENGSTROM FLEXIMA II
    Manufacturer
    MEDICAL AND INDUSTRIAL EQUIPMENT
    Date Cleared
    1997-11-12

    (237 days)

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

    MEDICAL AND INDUSTRIAL EQUIPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments.
    Device Description
    These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments.
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