title: Cardiovascular devices; classification of electrocardiograph electrodes. Final rule.
abstract: 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.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004562:Electrocardiography / Q000295:instrumentation*; D004566:Electrodes / Q000145:classification*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D011356:Product Labeling / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration