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510(k) Data Aggregation
K Number
K061102Device Name
PRIMA ANAESTHESIA MACHINE
Manufacturer
PENLON LTD.
Date Cleared
2006-07-28
(100 days)
Product Code
BSZ
Regulation Number
868.5160Why 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
K041076Device Name
DELTA T
Manufacturer
PENLON LTD.
Date Cleared
2004-08-09
(105 days)
Product Code
CAD
Regulation Number
868.5880Why 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
K010317Device Name
AV 800 VENTILATOR
Manufacturer
PENLON LTD.
Date Cleared
2001-07-23
(171 days)
Product Code
CBK
Regulation Number
868.5895Why 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
K010318Device Name
PRIMA OXYGEN MONITOR
Manufacturer
PENLON LTD.
Date Cleared
2001-07-23
(171 days)
Product Code
CCL
Regulation Number
868.1720Why 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
K002343Device Name
SIGMA DELTA
Manufacturer
PENLON LTD.
Date Cleared
2001-06-08
(311 days)
Product Code
CAD
Regulation Number
868.5880Why 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
K961468Device Name
QUIK-FIL VAPORIZER KEYED FILLER
Manufacturer
PENLON LTD.
Date Cleared
1996-07-16
(90 days)
Product Code
CAD
Regulation Number
868.5880Why 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
K960944Device Name
PPV VAPORIZER (MODIFICATION)
Manufacturer
PENLON LTD.
Date Cleared
1996-04-02
(49 days)
Product Code
CAD
Regulation Number
868.5880Why 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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