De Novo DEN200022
- Device
- Analytic for Hemodynamic Instability (AHI)
- Contact
- jennifer a baird
- De Novo number
- DEN200022
- Product code
- QNV
- Regulation
- 870.2220
- Classification name
- adjunctive hemodynamic indicator with decision point
- Decision
- granted (DENG)
- Decision date
- 2021-03-01
- Date received
- 2020-04-03
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QNV
- Device name
- Adjunctive Hemodynamic Indicator With Decision Point
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.2220
- Implant
- N
- Life sustain/support
- N