510(k) DEN220048
- Device
- Neoasis
- Applicant
- Invictus Medical, Inc.
- 510(k) number
- DEN220048
- Product code
- QWX
- Decision
- Unknown (DENG)
- Decision date
- 2023-06-16
- Date received
- 2022-07-25
- Regulation
- 880.5405
- Classification name
- Active Noise Attenuation System For Infant Incubators
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- George Hutchinson
- Address
- 16601 Blanco Rd., Suite 120 San Antonio TX US 78232 78232
Source Documents
510(k) summary PDF not indicated by FDA