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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 874 - EAR, Nose, and Throat Devices |
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Subpart B - Diagnostic Devices |
§ 874.1070 - Short increment sensitivity index (SISI) adapter.
Latest version.
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§ 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]