510(k) K993641

METALYZER, MODEL 2; METALYZER, MODEL 3 by Cortex Biophysik GmbH — Product Code BTY

K993641 is an FDA 510(k) premarket notification submitted by Cortex Biophysik GmbH for the device "METALYZER, MODEL 2; METALYZER, MODEL 3". The FDA issued a decision of Substantially Equivalent on December 14, 2000. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Cortex Biophysik GmbH has at least 1 other 510(k) clearance on record.