21 CFR § 868.5650 Anesthesiology Devices

§ 868.5650 Esophageal obturator.

Current through Sep 8, 2026 · Read all of Part 868

(a) Identification. An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.

(b) Classification. Class II (performance standards).

← § 868.5640 Medicinal nonventilatory nebulizer (atomizer).§ 868.5655 Portable liquid oxygen unit. →