CONCHAPAK OXYGEN DILUTER
Device Facts
| Record ID | K780011 |
|---|---|
| Device Name | CONCHAPAK OXYGEN DILUTER |
| Applicant | Respiratory Care, Inc. |
| Product Code | BYF · Anesthesiology |
| Decision Date | Feb 2, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5600 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.