21 CFR 870.5900 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Cardiovascular Devices (§ 870.1 To § 870.5925) — Cardiovascular Therapeutic Devices (§ 870.5050 To § 870.5925) — Thermal regulating system.

4 Aug 2016

(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 CFR 870.5900