StacksVerified U.S. regulatory reference

21 CFR §868.5270

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (performance standards).