eCFR Reference Browser

---

title: "21 CFR §882.1410"

source: "https://www.ecfr.gov/current/title-21/section-882.1410"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "882"

part_subject: "NEUROLOGICAL DEVICES"

subpart_code: "B"

subpart_subject: "Neurological Diagnostic Devices"

section_number: "882.1410"

section_subject: "Electroencephalograph electrode/lead tester."

cfr_reference: "21 CFR 882.1410"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

§882.1410 - Electroencephalograph electrode/lead tester.