www.fdanews.com/articles/138660-fda-reclassifies-ecg-electrodes-from-class-iii-to-class-ii
FDA Reclassifies ECG Electrodes From Class III to Class II
July 25, 2011
Electrocardiograph electrodes intended to acquire and transmit the electrical signals at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram are no longer Class III devices.
Devices & Diagnostics Letter
Devices & Diagnostics Letter