21 CFR § 870.2710 Cardiovascular Devices

§ 870.2710 Ear oximeter.

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

⚠ 3 pending changes to Part 870

(a) Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

(b) Classification. Class II (performance standards).

← § 870.2705 Infant pulse rate and oxygen saturation monitor for over-the-counter use.§ 870.2720 Hyperoxia monitoring device adjunct to pulse oximetry. →