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510(k) Data Aggregation
K Number
K041773Device Name
OXYGEN MEDICELS, CITICELS
Manufacturer
Date Cleared
2004-07-15
(14 days)
Product Code
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
CITY TECHNOLOGY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The City Technology Medical replacement oxygen sensor is intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.
Device Description
These medical Oxygen sensors are based on the amperometric electrochemical measurement principle. The sensors comprise a plastic body in which are two electrodes, a precious metal cathode and a lead anode immersed in a liquid electrolyte solution. Oxygen flows into the sensor through a solid membrane, which limits the flow and controls the output signal. Inside the sensor Oxygen reacts on the cathode to form hydroxyl ions. These hydroxyl ions then oxidise the metal anode. The electrons consumed at the cathode are supplied from the anode via the external circuit where a resistor is placed so that the voltage produced may be monitored. This voltage signal then constitutes a measure of the flux of Oxygen into the sensor and hence the partial pressure of Oxygen in front of the membrane.
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