Zdrowie i gospodarka · 21.07.2011
Cardiovascular Devices; Classification of Electrocardiograph Electrodes
The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.