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510(k) Data Aggregation

    K Number
    K041430
    Device Name
    BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
    Manufacturer
    BLEASE MEDICAL EQUIPMENT LTD.
    Date Cleared
    2004-10-07

    (132 days)

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

    BLEASE MEDICAL EQUIPMENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blease Frontline Sirius Range, Anaesthesia Machines are intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
    Device Description
    The Frontline Sirius is similar to the cleared Frontline Plus anaesthesia machine and the 6200 ventilator. The size and shape of the cabinet are the different, but the pneumatic systems and ventilator are the same.
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    K Number
    K003251
    Device Name
    BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
    Manufacturer
    BLEASE MEDICAL EQUIPMENT LTD.
    Date Cleared
    2001-05-23

    (218 days)

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

    BLEASE MEDICAL EQUIPMENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001727
    Device Name
    MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
    Manufacturer
    BLEASE MEDICAL EQUIPMENT LTD.
    Date Cleared
    2000-08-09

    (64 days)

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

    BLEASE MEDICAL EQUIPMENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982132
    Device Name
    BLEASE 6200 ANAESTHESIA VENTILATOR
    Manufacturer
    BLEASE MEDICAL EQUIPMENT LTD.
    Date Cleared
    1999-04-15

    (302 days)

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

    BLEASE MEDICAL EQUIPMENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blease 6200 anaesthesia ventilator is an advanced microprocessor (controller) specifically designed for controlled, pneumatically powered ventilation of adult and paediatric patients under general anaesthesia. It is designed for use with a circle type absorber and is ideally suited to both low-flow and high flow applications. It is assumed the ventilator may also be used with a Jackson-Rees/Ayres T-piece type paediatric circuit with no modification being necessary. The device is intended for use only by a suitably qualified physician.
    Device Description
    The Blease 6200 anaesthesia ventilator is an advanced microprocessor (controller) specifically designed for controlled, pneumatically powered ventilation of adult and paediatric patients under general anaesthesia.
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    K Number
    K982137
    Device Name
    BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
    Manufacturer
    BLEASE MEDICAL EQUIPMENT LTD.
    Date Cleared
    1999-04-09

    (296 days)

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

    BLEASE MEDICAL EQUIPMENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blease Frontline Genius Range, Anaesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
    Device Description
    Not Found
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