CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
Device Facts
| Record ID | K861758 |
|---|---|
| Device Name | CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA |
| Applicant | Life Design Systems, Inc. |
| Product Code | BYE · Anesthesiology |
| Decision Date | Jul 14, 1986 |
| 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.
