21 CFR § 870.5900 Cardiovascular Devices

§ 870.5900 Thermal regulating system.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.5800 Compressible limb sleeve.§ 870.5910 Esophageal thermal regulation device. →