510(k) K102483

SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 by Sunset Healthcare Solutions, LLC — Product Code CAH

K102483 is an FDA 510(k) premarket notification submitted by Sunset Healthcare Solutions, LLC for the device "SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104". The FDA issued a decision of Substantially Equivalent on September 13, 2011. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Sunset Healthcare Solutions, LLC has at least 1 other 510(k) clearance on record.