Code of Federal Regulations · Section
§ 868.5270 — Breathing System Heater
21 C.F.R. § 868.5270
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(a) Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351