510(k) K790936

MODEL 114 TREONIC H150 HAEMOHEATER by Vickers America Medical Corp. — Product Code KZL

K790936 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "MODEL 114 TREONIC H150 HAEMOHEATER". The FDA issued a decision of Substantially Equivalent on September 4, 1979. The device falls under product code KZL (Device, Warming. Blood And Plasma), a Class II device regulated under 21 CFR 864.9205. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.