DEN220048 is an FDA 510(k) submission for the Neoasis. This device is classified as a Active Noise Attenuation System For Infant Incubators (Class II - Special Controls, product code QWX).
Submitted by Invictus Medical, Inc. (San Antonio, US). The FDA issued a Not Cleared (DENG) decision on June 16, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5405. 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) Number | DEN220048 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 25, 2022 |
| Decision Date | June 16, 2023 |
| Days to Decision | 326 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QWX - Active Noise Attenuation System For Infant Incubators |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5405 |
| 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. |