e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart B → §882.1310 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart B—Neurological Diagnostic Devices
(a) Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.
(b) Classification. Class II (performance standards).