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Code of Federal Regulations (Last Updated: April 5, 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 882 - Neurological Devices |
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Subpart B - Neurological Diagnostic Devices |
§ 882.1320 - Cutaneous electrode.
Latest version.
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§ 882.1320 Cutaneous electrode.
(a) Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
(b) Classification. Class II (performance standards).