510(k) K910061

K-MODULE II HEAT THERAPY SYSTEM by Baxter Healthcare Corp — Product Code ILO

K910061 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "K-MODULE II HEAT THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 13, 1991. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Baxter Healthcare Corp has 507 other 510(k) clearances on record.