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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 |
§ 870.2700 - Oximeter.
Latest version.
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§ 870.2700 Oximeter.
(a) Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
(b) Classification. Class II (performance standards).