21 CFR 874.1070 - Short increment sensitivity index (SISI) adapter.

§ 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]

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