BIVONA(R) ICU ENDOTRACHEAL TUBE
Device Facts
| Record ID | K931749 |
|---|---|
| Device Name | BIVONA(R) ICU ENDOTRACHEAL TUBE |
| Applicant | Bivona Medical Technologies |
| Product Code | BTR · Anesthesiology |
| Decision Date | Aug 10, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5730 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.