510(k) K041244

POLYGRAM NET BIOFEEDBACK APPLICATION by Medtronic Vascular — Product Code HCC

K041244 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "POLYGRAM NET BIOFEEDBACK APPLICATION". The FDA issued a decision of Substantially Equivalent on August 12, 2004. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Medtronic Vascular has at least 10 other 510(k) clearances on record.