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510(k) Data Aggregation
K Number
K240375Device Name
V80 Anesthetic Vaporizer (V80)
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., LTD.
Date Cleared
2024-10-31
(267 days)
Product Code
CAD
Regulation Number
868.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.
V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.
V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.
V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.
Device Description
V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.
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K Number
K172702Device Name
Tec 820, Tec 850
Manufacturer
Datex-Ohmeda, Inc.
Date Cleared
2018-01-04
(119 days)
Product Code
CAD
Regulation Number
868.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tec 820 and Tec 850 vaporizers are designed for use in continuous flow techniques of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed for use only with General Electric's Selectatec Series Manifolds.
Device Description
The Datex-Ohmeda Tec™ 820 and Tec 850 vaporizers are designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. The vaporizers are available in Sevoflurane and Isoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
The output concentration of the Tec 820/850 vaporizer is regulated by the "variable flow-split" method, where a total flow of fresh gas from upstream enters the vaporizer where it is split into two streams. One stream flows into the fresh gas bypass circuit and the other stream flows through the vaporizing chamber where it is saturated with the vapor of the liquid anesthetic agent.
Both gas paths have methods to regulate the flow to achieve desired total output agent concentration. Before exiting the vaporizer through the gas outlet, the split gas streams are joined. The combined total flow then flows out from the vaporizer via the Selectatec circuitry to the anesthesia gas delivery system.
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K Number
K150167Device Name
V60 Anesthetic Vaporizer
Manufacturer
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Date Cleared
2015-06-30
(155 days)
Product Code
CAD
Regulation Number
868.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system.
The V60 Anesthetic Vaporizer is available in models specific for use with Isoflurane and models available specific for use with Sevoflurane.
Device Description
The V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer. Fresh gas enters the vaporizer and is divided into two pathways: carrier gas (through pressure compensation and liquid vaporizing systems) and diluted gas (through bypass and temperature compensation systems). These two pathways mix to form mixed anesthetic gas with a controlled concentration before the outlet. It includes a filling system, can be installed on an anesthetic delivery system, evaporates liquid anesthetic agents to deliver mixed gas of controlled concentration, and provides a mechanism to adjust output concentration.
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K Number
K110608Device Name
SEVOFLURANE VAPORIZER ADAPTOR
Manufacturer
PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)
Date Cleared
2011-07-20
(139 days)
Product Code
CAD
Regulation Number
868.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sevoflurane Vaporizer Adaptor is intended to be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
Device Description
The Sevoflurane Vaporizer Adaptor will fit securely to the bottle and the vaporizer, ensuring minimal leakage. The adaptor is designed for use with QuikFil™ vaporizer filling technology and it is intended for multiple uses. The device complies with the requirements of ISO 5360:2006.
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K Number
K060331Device Name
SIGMA ALPHA VAPORIZER
Manufacturer
PENLON LIMITED
Date Cleared
2006-05-10
(90 days)
Product Code
CAD
Regulation Number
868.5880Why did this record match?
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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
K053564Device 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
868.5880Why did this record match?
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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
K051666Device Name
GAV - GENERAL ANAESTHETIC VAPORIZER
Manufacturer
GENERAL ANAESTHETIC SERVICES LIMITED
Date Cleared
2005-08-23
(62 days)
Product Code
CAD
Regulation Number
868.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GAV General Anesthetic Vaporizer is a concentration-calibrated device intended to deliver specific anesthetic agents into the fresh gas supply of an anesthesia workstation or anesthesia gas machine. The volatile agents intended to be used with this device are: Isoflurane, Sevoflurane and Halothane.
Device Description
The GAV – General Anaesthetic Vaporizer is designed for use in continuous flow techniques of general anesthesia. It has a finely graduation that occipis and temperatures. Safety features such as unteriged Over a wide range of ther see incorporated together with many convenience features intenoun, Nor-oplir and Reyou Fillor are meet persition. GAV vaporizers are agent specific and are clearly labelled and colour coded for additional safety.
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K Number
K042276Device Name
D-VAPOR
Manufacturer
DRAEGER MEDICAL, INC.
Date Cleared
2004-09-23
(31 days)
Product Code
CAD, DEV
Regulation Number
868.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.
Device Description
The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of Desflurane anesthetic vapor in concentrations of 2 to 18 vol.%.
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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?
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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
K031027Device Name
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
Manufacturer
DATEX-OHMEDA, INC.
Date Cleared
2003-06-26
(86 days)
Product Code
CAD
Regulation Number
868.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane, sevoflurane and enflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
Device Description
The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, sevoflurane and enflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
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