PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
Device Facts
| Record ID | K954750 |
|---|---|
| Device Name | PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE |
| Applicant | Unomedical Sdn Bhd |
| Product Code | BTR · Anesthesiology |
| Decision Date | Dec 8, 1995 |
| 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.