21 C.F.R. § 862.3220

Current through March 31, 2024
Section 862.3220 - Carbon monoxide test system
(a)Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9 .

21 C.F.R. §862.3220

52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019