510(k) K131904

MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA by Ameriwater — Product Code FIP

K131904 is an FDA 510(k) premarket notification submitted by Ameriwater for the device "MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA". The FDA issued a decision of Substantially Equivalent on November 13, 2013. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Ameriwater has at least 10 other 510(k) clearances on record.