Active Noise Attenuation System For Infant Incubators
The active noise attenuation system for infant incubators (product code QWX) is a Class 2 General Hospital device (regulation 880.5405) that captures environmental noise and outputs noise-cancelling acoustic sound waves to attenuate noise levels within infant incubators in healthcare settings. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWX
- Device Class
- FDA class 2
- Regulation Number
- 880.5405
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220048 | Neoasis | Jun 16, 2023 | Unknown | Invictus Medical, Inc. |