21 CFR 870.5900 — System, Thermal Regulating

Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5900

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DWJSystem, Thermal Regulating21583rd Party
NCXSystem, Hypothermia, Intravenous, Cooling226
NZEHyperthermia Monitor263rd Party
Innolitics

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