510(k) K030271

VENTLAB BACTERIAL FILTER, MODEL BF100 by Ventlab Corp. — Product Code CAH

K030271 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "VENTLAB BACTERIAL FILTER, MODEL BF100". The FDA issued a decision of Substantially Equivalent on July 7, 2003. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Ventlab Corp. has at least 10 other 510(k) clearances on record.