Code of Federal Regulations · Section
§ 882.1310 — Cortical Electrode
21 C.F.R. § 882.1310
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351