Code of Federal Regulations · Section

§ 870.5900 — Thermal Regulating System

21 C.F.R. § 870.5900

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(a) Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

(b) Classification. Class II (performance standards).

21 C.F.R. § 870.5800 21 C.F.R. § 870.5910

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