BREEZE SLEEPGEAR WITH DREAMSEAL
Device Facts
| Record ID | K002001 |
|---|---|
| Device Name | BREEZE SLEEPGEAR WITH DREAMSEAL |
| Applicant | Puritan Bennett Corp. |
| Product Code | BZD · Anesthesiology |
| Decision Date | Sep 6, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
