Title 21: Food and Drugs
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/ PART 868 - ANESTHESIOLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 868.5650 Esophageal obturator.
§ 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).