QWX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Active Noise Attenuation System For Infant Incubators
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5405
- Medical specialty
- General Hospital
- FDA definition
- A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Neoasis (DEN220048) | Invictus Medical, Inc. | 2023-06-16 |
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