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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 870 - Cardiovascular Devices |
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Subpart C - Cardiovascular Monitoring Devices |
§ 870.2340 - Electrocardiograph.
Latest version.
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§ 870.2340 Electrocardiograph.
(a) Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
(b) Classification. Class II (performance standards).