510(k) K962045

ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT by Mallinckrodt Medical — Product Code CAH

K962045 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT". The FDA issued a decision of Substantially Equivalent on November 26, 1996. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Mallinckrodt Medical has at least 10 other 510(k) clearances on record.