§874.1070. Short increment sensitivity index (SISI) adapter.
21 C.F.R. § 874.1070
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.
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.
Notes, amendments, and revision history
Amendments
[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
Amendments
[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000]