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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 |
§ 870.2330 - Echocardiograph.
Latest version.
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§ 870.2330 Echocardiograph.
(a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.
(b) Classification. Class II (performance standards).