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e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 870 → Subpart C → §870.2700 |
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices
§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).