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Electronic Code of Federal Regulations

e-CFR data is current as of April 8, 2020

Title 21Chapter ISubchapter HPart 870Subpart F → §870.5900


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart F—Cardiovascular Therapeutic Devices


§870.5900   Thermal regulating system.

(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).

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