21 CFR § 870.2700 Cardiovascular Devices

§ 870.2700 Oximeter.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.2675 Oscillometer.§ 870.2705 Infant pulse rate and oxygen saturation monitor for over-the-counter use. →