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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.

Source: Federal Register — Health and Human ServicesOpen original release →