21 CFR § 882.1410 Neurological Devices

§ 882.1410 Electroencephalograph electrode/lead tester.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, 2001]

← § 882.1400 Electroencephalograph.§ 882.1420 Electroencephalogram (EEG) signal spectrum analyzer. →