SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Device Facts
| Record ID | K962492 |
|---|---|
| Device Name | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
| Applicant | Nidek Medical Products, Inc. |
| Product Code | BYE · Anesthesiology |
| Decision Date | Jan 23, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5965 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.