SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
Device Facts
| Record ID | K861463 |
|---|---|
| Device Name | SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE |
| Applicant | Shiley, Inc. |
| Product Code | BTR · Anesthesiology |
| Decision Date | May 6, 1986 |
| 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.