510(k) K043357

TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 by Linde Medical Sensors AG — Product Code LKD

K043357 is an FDA 510(k) premarket notification submitted by Linde Medical Sensors AG for the device "TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009". The FDA issued a decision of Substantially Equivalent on March 4, 2005. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Linde Medical Sensors AG has at least 3 other 510(k) clearances on record.