21 CFR 870.2360
§ 870.2360 Electrocardiograph electrode.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.2360, § 870.2360 Electrocardiograph electrode, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89925
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.