510(k) K873487

HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES by Water Pure, Inc. — Product Code FIP

K873487 is an FDA 510(k) premarket notification submitted by Water Pure, Inc. for the device "HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on October 23, 1987. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Water Pure, Inc. has at least 1 other 510(k) clearance on record.