EVAC-TUBE
Device Facts
| Record ID | K894032 |
|---|---|
| Device Name | EVAC-TUBE |
| Applicant | Sharn, Inc. |
| Product Code | CAO · Anesthesiology |
| Decision Date | Aug 31, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5650 |
| Device Class | Class 2 |
Regulatory Classification
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.
