510(k) K971571

RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT by Waters Instruments, Inc. — Product Code KDN

K971571 is an FDA 510(k) premarket notification submitted by Waters Instruments, Inc. for the device "RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT". The FDA issued a decision of Substantially Equivalent on July 29, 1997. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Waters Instruments, Inc. has at least 10 other 510(k) clearances on record.