RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
Device Facts
| Record ID | K000705 |
|---|---|
| Device Name | RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 |
| Applicant | Respironics, Inc. |
| Product Code | BZD · Anesthesiology |
| Decision Date | Sep 8, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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.
