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e-CFR data is current as of July 13, 2020

Title 21Chapter ISubchapter HPart 882Subpart B → §882.1540


Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart B—Neurological Diagnostic Devices


§882.1540   Galvanic skin response measurement device.

(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.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]

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