510(k) K132679

AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER by Galemed Corp. — Product Code CAH

K132679 is an FDA 510(k) premarket notification submitted by Galemed Corp. for the device "AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER". The FDA issued a decision of Substantially Equivalent on April 18, 2014. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Galemed Corp. has at least 6 other 510(k) clearances on record.