21 C.F.R. § 870.2700

Current through October 31, 2024
Section 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).

21 C.F.R. § 870.2700