C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 870—CARDIOVASCULAR DEVICES › Subpart F—Cardiovascular Therapeutic Devices

21 C.F.R. § 870.5900

Thermal regulating system

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(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).

Notes of Decisions
Cited in 1 case, 1998–1998 · leading case: Leslie v. Cincinnati Sub-Zero Prods., Inc., 961 S.W.2d 799 (Ky. Ct. App. 1998).
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Leslie v. Cincinnati Sub-Zero Prods., Inc., 961 S.W.2d 799 (Ky. Ct. App. 1998). “21 C.F.R. § 870.5900 (1997). The section of MDA which is at the root of the preemption question is 21 U.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.