21 CFR 882.1540 — Device, Galvanic Skin Response Measurement
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1540
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | 2 | 26 |
Special Controls
GZO — Device, Galvanic Skin Response Measurement
*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.
eCFR
