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  • Title: Cardiovascular devices; classification of electrocardiograph electrodes. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2011 Jul 21; 76(140):43582-5. PubMed ID: 21780327.
    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.
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