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510(k) Data Aggregation

    K Number
    K061102
    Device Name
    PRIMA ANAESTHESIA MACHINE
    Manufacturer
    PENLON LTD.
    Date Cleared
    2006-07-28

    (100 days)

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

    PENLON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Penlon Prima Anaesthesia Machine is intended to provide controlled concentrations and flows of anaesthesia gases into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will deliver this fresh gas to the patient. The Penlon Prima Anaesthesia Machine is designed to deliver a combination of medical gases and volatile anaesthetic agents to a breathing system.
    Device Description
    The Prima Anaesthesia Machine is a continuous flow anaesthesia gas delivery device that enables the anesthetist to deliver mixtures of oxygen, air, nitrous oxide and volatile anaesthetic agents to a patient. Although the device has no direct contact with the patient it has an important role to play in a system that delivers anaesthesia gases to a patient. The device comprises a trolley, a gas delivery system, gas control system. safety systems and facilities to mount and interface other modules of an anaesthesia delivery system, e.g. ventilators, vaporizers, absorbers plus other accessories. The design of the device conforms to all relevant national and international standards covering the safety of anesthesia systems.
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    K Number
    K041076
    Device Name
    DELTA T
    Manufacturer
    PENLON LTD.
    Date Cleared
    2004-08-09

    (105 days)

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

    PENLON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sigma Delta 'T' vaporizer range is designed to attach to the back bar of an anaesthetic machine and deliver controlled concentrations of anaesthesia gasses into a fresh gas. The fresh gas is then delivered into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will then deliver this fresh gas mixture to the patient. The Vaporizer is calibrated in Vol % of the fresh gas flow and is compensated for changes in both fresh gas flows and temperature changes within the specified range. The indicated use of the Sigma Delta 'T' has therefore not changed from that of the legally marketed device the Sigma Delta.
    Device Description
    Anaesthetic Vaporizer
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    K Number
    K010317
    Device Name
    AV 800 VENTILATOR
    Manufacturer
    PENLON LTD.
    Date Cleared
    2001-07-23

    (171 days)

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

    PENLON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010318
    Device Name
    PRIMA OXYGEN MONITOR
    Manufacturer
    PENLON LTD.
    Date Cleared
    2001-07-23

    (171 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    PENLON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002343
    Device Name
    SIGMA DELTA
    Manufacturer
    PENLON LTD.
    Date Cleared
    2001-06-08

    (311 days)

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

    PENLON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961468
    Device Name
    QUIK-FIL VAPORIZER KEYED FILLER
    Manufacturer
    PENLON LTD.
    Date Cleared
    1996-07-16

    (90 days)

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

    PENLON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960944
    Device Name
    PPV VAPORIZER (MODIFICATION)
    Manufacturer
    PENLON LTD.
    Date Cleared
    1996-04-02

    (49 days)

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

    PENLON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Penlon PPV Vaporizers
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