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510(k) Data Aggregation
K Number
K041430Device 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
868.5160Why 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
K003251Device 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
868.5160Why 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
K001727Device 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
868.5160Why 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
K982132Device Name
BLEASE 6200 ANAESTHESIA VENTILATOR
Manufacturer
BLEASE MEDICAL EQUIPMENT LTD.
Date Cleared
1999-04-15
(302 days)
Product Code
CBK
Regulation Number
868.5895Why 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
K982137Device Name
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
Manufacturer
BLEASE MEDICAL EQUIPMENT LTD.
Date Cleared
1999-04-09
(296 days)
Product Code
BSZ
Regulation Number
868.5160Why 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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