510(k) K895775

CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM by Medtronic Vascular — Product Code KTB

K895775 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 23, 1990. 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.