510(k) K121382

WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] by Westmed, Inc. — Product Code CAH

K121382 is an FDA 510(k) premarket notification submitted by Westmed, Inc. for the device "WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]". The FDA issued a decision of Substantially Equivalent on December 6, 2012. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Westmed, Inc. has at least 7 other 510(k) clearances on record.