21 C.F.R. § 868.5650

Current through April 30, 2024
Section 868.5650 - Esophageal obturator
(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).

21 C.F.R. § 868.5650