Galvanic skin response measurement device.

21 C.F.R. § 882.1540
in effectEffective: 2024-07-01
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(a) Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. (b) Classification. Class II (special 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.

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21 C.F.R. § 882.1540 — Galvanic skin response measurement device | Code of Federal Regulations | Corpus