QWX — Active Noise Attenuation System For Infant Incubators Class II
FDA product code QWX covers "Active Noise Attenuation System For Infant Incubators", a Class II medical device regulated under 21 CFR 880.5405. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWX
- Device Class
- Class II
- Regulation Number
- 880.5405
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220048 | invictus medical | Neoasis | June 16, 2023 |