510(k) DEN220048
DEN220048 is an FDA 510(k) premarket notification submitted by Invictus Medical, Inc. for the device "Neoasis". The FDA issued a decision of De Novo Granted on June 16, 2023. The device falls under product code QWX (Active Noise Attenuation System For Infant Incubators), a Class II device regulated under 21 CFR 880.5405. Invictus Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 16, 2023
- Date Received
- July 25, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Active Noise Attenuation System For Infant Incubators
- Device Class
- Class II
- Regulation Number
- 880.5405
- Review Panel
- HO
- Submission Type
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.