CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR882.1560]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 882 -- NEUROLOGICAL DEVICES

Subpart B - Neurological Diagnostic Devices

Sec. 882.1560 Skin potential measurement device.

(a) Identification. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.

(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]