510(k) K832059

IONOPHORELIC SWEAT STIM. CHLORIDE- by Medtronic Vascular — Product Code KTB

K832059 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "IONOPHORELIC SWEAT STIM. CHLORIDE-". The FDA issued a decision of Substantially Equivalent on August 24, 1983. The device falls under product code KTB (Device, Iontophoresis, Specific Uses), a Class II device regulated under 21 CFR 890.5525. Medtronic Vascular has at least 10 other 510(k) clearances on record.