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510(k) Data Aggregation
K Number
K193250Device Name
Irrigation Tubing with CO2 or Air
Manufacturer
KeyMed (Medical and Industrial Equipment) Ltd.
Date Cleared
2020-04-06
(133 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KeyMed (Medical and Industrial Equipment) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
Device Description
The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.
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K Number
K971030Device Name
MIE FALCON, DATEX ENGSTROM FLEXIMA II
Manufacturer
MEDICAL AND INDUSTRIAL EQUIPMENT
Date Cleared
1997-11-12
(237 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL AND INDUSTRIAL EQUIPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments.
Device Description
These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments.
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