21 C.F.R. § 874.1070 Short increment sensitivity index (SISI) adapter.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart B—Diagnostic Devices
§ 874.1070 Short increment sensitivity index (SISI) adapter.
