Title 21

SECTION 870.2710

870.2710 Ear oximeter.

§ 870.2710 Ear oximeter.

(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).