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

882.1430 - Electroencephalograph test signal generator.

  (a) Identification. An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph.

  (b) Classification. Class I (general 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 5173051778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]