Section 870.2360 - Electrocardiograph electrode(a)Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9 . The special control for this device is the FDA guidance document entitled "Class II Special Controls Guidance Document: Electrocardiograph Electrodes." See § 870.1(e) for availability information of guidance documents.45 FR 7907, Feb. 5, 1980, as amended at 76 FR 43585 , July 21, 2011