510(k) K002372

ACCESS ALERT GAUGE by Medisystems Corp. — Product Code KOC

K002372 is an FDA 510(k) premarket notification submitted by Medisystems Corp. for the device "ACCESS ALERT GAUGE". The FDA issued a decision of Substantially Equivalent on October 25, 2000. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Medisystems Corp. has at least 10 other 510(k) clearances on record.