510(k) K133829

AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF by Vivonic GmbH — Product Code FIP

K133829 is an FDA 510(k) premarket notification submitted by Vivonic GmbH for the device "AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF". The FDA issued a decision of Substantially Equivalent on April 22, 2014. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Vivonic GmbH has at least 1 other 510(k) clearance on record.