510(k) K920186

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS by Better Water, Inc. — Product Code FIP

K920186 is an FDA 510(k) premarket notification submitted by Better Water, Inc. for the device "WATER PURIFICATION SYSTEM FOR HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on June 13, 1995. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Better Water, Inc. has at least 4 other 510(k) clearances on record.