510(k) K951727

Z-WATCH SYSTEM by Prizm Medical, Inc. — Product Code IPF

K951727 is an FDA 510(k) premarket notification submitted by Prizm Medical, Inc. for the device "Z-WATCH SYSTEM". The FDA issued a decision of SN on November 21, 1995. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Prizm Medical, Inc. has at least 7 other 510(k) clearances on record.