De Novo DEN180021
- Device
- Early Bird Bleed Monitoring System
- Contact
- zaffer syed
- De Novo number
- DEN180021
- Product code
- QFJ
- Regulation
- 870.1345
- Classification name
- intravascular bleed monitor
- Decision
- granted (DENG)
- Decision date
- 2019-03-01
- Date received
- 2018-04-23
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QFJ
- Device name
- Intravascular Bleed Monitor
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.1345
- Implant
- N
- Life sustain/support
- N