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510(k) Data Aggregation

    K Number
    K060331
    Device Name
    SIGMA ALPHA VAPORIZER
    Manufacturer
    PENLON LIMITED
    Date Cleared
    2006-05-10

    (90 days)

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

    PENLON LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent - Suprane®, also know as Desflurane - and delivers controlled concentrations of the vaporized anaesthetic agent into a fresh gas that is then breathed by the patient. The Sigma Alpha Vaporizer is indicated for use by both adult and pediatric patients. The Sigma Alpha Vaporizer is not intended to be used with Enflurane, Halothane, Isoflurane or Sevoflurane, or for use in a breathing circuit. The Sigma Alpha Vaporizer is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.
    Device Description
    The Sigma Alpha Vaporizer is an electronic calibrated vaporizer that is designed to enrich the fresh gas flow of a continuous flow anaesthesia machine, when the vaporizer is connected directly between the flowmeter and the common gas outlet of the machine. The device has been developed in close co-operation with clinicians and the anaesthetic agent manufacturer.
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    K Number
    K053564
    Device Name
    KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
    Manufacturer
    PENLON LIMITED
    Date Cleared
    2006-03-03

    (71 days)

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

    PENLON LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keyed Filler Bottle Adaptor is intended to be used to enable the bottle, in which the anaesthetic agent is supplied by the pharmaceutical company, to be connected to the keyed filler port of an anaesthetic vaporizer. The Keyed Filler Bottle Adaptor provides a flexible connection that allows the liquid agent to be filled into, and drained from, the vaporizer by gravity. It is indicated for use with bottles of Halothane, Enflurane, Isoflurane and Sevoflurane that provide anaesthesia, via a vaporizer, to a patient connected to an anaesthetic machine. The Keyed Filler Bottle Adaptor is an accessory to a restricted medical device and is intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.
    Device Description
    The Keyed Filler Bottle Adaptor enables users to connect the bottle, in which the pharmaceutical company supplies specific liquid anaesthetic agents (Halothane, Enflurane, Isoflurane and Sevoflurane), to a compatible filling receptacle provided on an anaesthetic vaporizer, that is attached to an anaesthetic machine. Four versions of the adaptor are available, each one with a colour coded bottle connector and male adaptor (for connecting to the vaporizer). Each adaptor is specific to one of the anaesthetic agents named above and is considered to be an accessory to a vaporizer.
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    K Number
    K051222
    Device Name
    AV-S ANAESTHESIA VENTILATOR
    Manufacturer
    PENLON LIMITED
    Date Cleared
    2005-09-23

    (134 days)

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

    PENLON LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Respiratory Therapists and Technicians under the direction of a Physician. Specifically the ventilator is indicated for use by both adult and pediatric patients.
    Device Description
    The AV-S Ventilator is a software controlled multi-mode ventilator designed for mechanical ventilation of adult and paediatric patients under general anaesthesia. In addition, in spontaneous mode, it can be used to monitor anaesthetised patients. It is designed for use in closed circuit anaesthesia and also to drive a Mapleson D circuit. The AV-S Ventilator is also available with a remote display screen unit that can be affixed to an anaesthesia machine and be located remotely from the ventilator control unit. The display screen is affixed to the anaesthesia ventilator by a swivel mounting arm. An interconnecting cable is provided to transmit data between the control unit and the remote display screen unit.
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