510(k) K101439

CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P by Codonics, Inc. — Product Code BSZ

K101439 is an FDA 510(k) premarket notification submitted by Codonics, Inc. for the device "CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P". The FDA issued a decision of Substantially Equivalent on February 7, 2011. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Codonics, Inc. has at least 6 other 510(k) clearances on record.