510(k) K131626

EXCELERON BACTERIAL FILTERS by Exceleron Medical — Product Code CAH

K131626 is an FDA 510(k) premarket notification submitted by Exceleron Medical for the device "EXCELERON BACTERIAL FILTERS". The FDA issued a decision of Substantially Equivalent on February 26, 2014. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Exceleron Medical has at least 1 other 510(k) clearance on record.