510(k) K813176

GEL ELECTRODE by Dyn-A-Med Products — Product Code DRX

K813176 is an FDA 510(k) premarket notification submitted by Dyn-A-Med Products for the device "GEL ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 29, 1981. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Dyn-A-Med Products has at least 4 other 510(k) clearances on record.