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Code of Federal Regulations (Last Updated: November 8, 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 |
§ 870.2770 - Impedance plethysmograph.
Latest version.
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§ 870.2770 Impedance plethysmograph.
(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.
(b) Classification. Class II (performance standards). special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]