510(k) K002506

BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT by Sims Portex, Inc. — Product Code CAH

K002506 is an FDA 510(k) premarket notification submitted by Sims Portex, Inc. for the device "BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on December 14, 2000. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Sims Portex, Inc. has at least 10 other 510(k) clearances on record.