510(k) K032291

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM by Linde Medical Sensors AG — Product Code DOA

K032291 is an FDA 510(k) premarket notification submitted by Linde Medical Sensors AG for the device "TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 24, 2004. The device falls under product code DOA (Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.), a Class II device regulated under 21 CFR 862.3320. Linde Medical Sensors AG has at least 3 other 510(k) clearances on record.