21 C.F.R. § 870.5900

Current through August 31, 2024
Section 870.5900 - Thermal regulating system
(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. § 870.5900