510(k) K111740

AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION by Ameriwater — Product Code FIP

K111740 is an FDA 510(k) premarket notification submitted by Ameriwater for the device "AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION". The FDA issued a decision of Substantially Equivalent on October 5, 2011. 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.