21 C.F.R. · Food and Drugs
21 C.F.R. § 862.3220

Carbon monoxide test system.

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21 C.F.R. § 862.3220 — Carbon monoxide test system.

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

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21 C.F.R. § 862.3220
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The regulatory text of 21 C.F.R. § 862.3220 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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