510(k) K032716

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) by Portex , Ltd. — Product Code CAH

K032716 is an FDA 510(k) premarket notification submitted by Portex , Ltd. for the device "PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)". The FDA issued a decision of Substantially Equivalent on November 28, 2003. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Portex , Ltd. has at least 10 other 510(k) clearances on record.