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510(k) Data Aggregation

    K Number
    K981845
    Device Name
    HAWK ANAESTHESIA INDUCTION UNIT
    Date Cleared
    1998-11-03

    (161 days)

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

    MEDICAL INDUSTRIAL EQUIPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation for adults and children above 5 kg body weight. It facilitates the control and administration of operator selected gas mixtures with anaesthetic agents . The anaesthetic agents are accurately dispensed by a suitable anaesthetic vaporiser, of the type specified, which may be safely and securely attached to the modular backbar. The Hawk provides safe and accurate gas flows to maintain patient respiration during induction of anaesthesia. It is specified for use with an oxygen monitor and other suitable monitoring, these monitors are specified in the operator's manual. The Hawk may be safely used with magnetic resonance imaging systems (MRJ) as it is MRI compatible.
    Device Description
    The MIE Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation.
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    K Number
    K980489
    Device Name
    VAPAMASTA 6
    Date Cleared
    1998-08-31

    (203 days)

    Product Code
    Regulation Number
    868.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INDUSTRIAL EQUIPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus. Their purpose of these devices is to vaporise an inhalable anaesthetic agent for which they have been calibrated and which is indicated on the labelling. They may be used for the induction and maintenance of a state of anaesthesia in humans during a medical procedure, usually involving a surgical operation. They may additionally be used for veterinary procedures. The devices are calibrated for a specific anaesthetic agent and vaporisers for the following anaesthetic agents are available in the Vapamasta 6 range; Halothane, Enflurane, Isoflurane or Sevoflurane.
    Device Description
    The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus.
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