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510(k) Data Aggregation
K Number
K043357Device Name
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
Manufacturer
LINDE MEDICAL SENSORS AG
Date Cleared
2005-03-04
(88 days)
Product Code
LKD, DPZ
Regulation Number
868.2480Why did this record match?
Applicant Name (Manufacturer) :
LINDE MEDICAL SENSORS AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Linde TOSCA 500 Monitoring 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 500 Monitoring System is designed for the simultaneous continous monitoring of transcutaneous PCO2 functional oxygen saturation SpO2 and pulse rate, using a single sensor (Tosca Sensor) applied to the ear lobe.
The system consists of a Tosca Monitor equipped with an integrated calibration unit which allows a fully automatic calibration of the PCO2 part of the sensor and also provides a storage facility for the sensor, and with the Masimo SET signal extraction technology for the calculation of the functional oxygen saturation and the pulse rate ; 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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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?
Applicant Name (Manufacturer) :
LINDE MEDICAL SENSORS AG
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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K Number
K003943Device Name
MICROGAS 7650 TRANSCUTANEOUS MONITOR
Manufacturer
LINDE MEDICAL SENSORS AG
Date Cleared
2001-05-04
(134 days)
Product Code
KLK
Regulation Number
868.2500Why did this record match?
Applicant Name (Manufacturer) :
LINDE MEDICAL SENSORS AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991644Device Name
MICROGAS 7650 TRANSCUTANEOUS MONITOR
Manufacturer
LINDE MEDICAL SENSORS AG
Date Cleared
1999-05-21
(8 days)
Product Code
KLK
Regulation Number
868.2500Why did this record match?
Applicant Name (Manufacturer) :
LINDE MEDICAL SENSORS AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous layer of the skin of an infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.
Device Description
Detailed description of the device is contained in the MicroGas 7650 Operator's Manual located in Appendix 2 of this document.
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