21 CFR 870.5900
§ 870.5900 Thermal regulating system.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.5900, § 870.5900 Thermal regulating system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90034
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.