Esophageal obturator.

21 C.F.R. § 868.5650
in effectEffective: 2024-07-01
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(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).

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