21 C.F.R. § 870.5900 Thermal regulating system.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart F—Cardiovascular Therapeutic Devices
§ 870.5900 Thermal regulating system.