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510(k) Data Aggregation
K Number
K032291Device Name
TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
Manufacturer
LINDE MEDICAL SENSORS AG
Date Cleared
2004-08-24
(397 days)
Product Code
DOA, LKD
Regulation Number
862.3320Why did this record match?
Product Code :
DOA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Linde TOSCA System is designed for the simultaneous continuous monitoring of transcutaneous PCO2, functional oxygen saturation SpO2 and pulse rate in adults and pediatrics.
Device Description
The Linde Tosca System is used for the simultaneous continuous monitoring of transcutaneous PCO2, functional oxygen saturation SpO2 and pulse rate, using a single sensor (Tosca Sensor) applied to the ear lobe.
The system consist of a TOSCA Monitor equipped with an integrated calibration unit which allows a fully automatic calibration and also provides a storage facility for the sensor; a TOSCA Sensor comprising the elements of an electrochemical Stow-Severinghaus-type carbon dioxide sensor and of an optical pulse oximetry sensor; supplies for the sensor preparation; supplies for the sensor attachment at the ear lobe; and a gas mixture for the sensor calibration.
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