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e-CFR data is current as of October 22, 2020

Title 21Chapter ISubchapter HPart 870Subpart C → §870.2770


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices


§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 (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]

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