CPAP SYSTEM, MODEL 102001
Device Facts
| Record ID | K001318 |
|---|---|
| Device Name | CPAP SYSTEM, MODEL 102001 |
| Applicant | Sims Portex, Inc. |
| Product Code | BYE · Anesthesiology |
| Decision Date | Jul 20, 2000 |
| 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.
