Title 21

SECTION 870.2360

870.2360 Electrocardiograph electrode.

§ 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]

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