Zdrowie i gospodarka · 21/07/2011

FDA Classifies Electrocardiograph Electrodes into Class II, Exempts from Premarket Notification Requirement

The US Food and Drug Administration (FDA) has classified electrocardiograph electrodes, used to capture and transmit heart signals, into Class II, a category requiring special controls, while exempting these devices from the need for a premarket notification, a requirement typically needed for new medical devices.