TITLE 21 - FOOD AND DRUGS

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

SUBCHAPTER H - MEDICAL DEVICES

PART 874 - EAR, NOSE, AND THROAT DEVICES

subpart b - DIAGNOSTIC DEVICES

874.1070 - Short increment sensitivity index (SISI) adapter.

  (a) Identification. A short increment sensitivity index (SISI) adapter is a device used with an audiometer in diagnostic hearing evaluations. A SISI adapter provides short periodic sound pulses in specific small decibel increments that are intended to be superimposed on the audiometer's output tone frequency.

  (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 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000]