FNC · Tent, Pediatric Aerosol
Anesthesiology · 21 CFR 868.5710 · Class 2
Overview
| Product Code | FNC |
|---|---|
| Device Name | Tent, Pediatric Aerosol |
| Regulation | 21 CFR 868.5710 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.
Classification Rationale
Class II (performance standards).
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884922 | THE BREATHE EASE NURSERY VAPOR TENT | Cal-Trends Products | Feb 3, 1989 | SESE |
Top Applicants
- Cal-Trends Products — 1 clearance
