SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)
Device Facts
| Record ID | K955482 |
|---|---|
| Device Name | SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) |
| Applicant | Advantage Medical Services, Inc. |
| Product Code | FOG · Anesthesiology |
| Decision Date | Jan 30, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.
