Code of Federal Regulations · Section

§ 862.1120 — Blood Gases (pco2, Po2) And Blood Ph Test System

21 C.F.R. § 862.1120

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(a) Identification. A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

(b) Classification. Class II.

21 C.F.R. § 862.1118 21 C.F.R. § 862.1130

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