§882.1320. Cutaneous electrode.
21 C.F.R. § 882.1320
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.