21 CFR 868.5650 — Airway, Esophageal (Obturator)

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5650

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
CAOAirway, Esophageal (Obturator)26Life-Sustaining
Innolitics

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