KHA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mask, Scavenging
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5590
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1995: 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 |
|---|---|---|---|
| UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) (K970046) | Accutron, Inc. | 1997-03-28 | + Add |
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