FNC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tent, Pediatric Aerosol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5710
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1996: 1 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| THE BREATHE EASE NURSERY VAPOR TENT (K884922) | Cal-Trends Products | 1989-02-03 | + Add |
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