{"data":{"id":"us/21-cfr-870.2360","jurisdiction":"us","citation":"21 CFR 870.2360","heading":"Electrocardiograph electrode.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 870—CARDIOVASCULAR DEVICES","Subpart C—Cardiovascular Monitoring Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"e78fa1d3261fb01de2019716c5a60883699a8687b6c090303f72d3c5db7d17ad","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.2350","next":"us/21-cfr-870.2370"},"notice":"GroundRules: Original legal text. Not legal advice."}