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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 B - Cardiovascular Diagnostic Devices |
§ 870.1660 - Indicator injector.
Latest version.
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§ 870.1660 Indicator injector.
(a) Identification. An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output.
(b) Classification. Class II (performance standards).