De Novo DEN080009
- Device
- AIRPURGE
- Contact
- ihsan a haddad
- De Novo number
- DEN080009
- Product code
- OKL
- Regulation
- 880.5445
- Classification name
- intravascular administration set, automated air removal system
- Decision
- granted (DENG)
- Decision date
- 2014-03-04
- Date received
- 2008-10-29
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OKL
- Device name
- Intravascular Administration Set, Automated Air Removal System
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.5445
- Implant
- N
- Life sustain/support
- N