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De Novo DEN230003
- Device
- Viz HCM
- Contact
- gregory ramina
- De Novo number
- DEN230003
- Product code
- QXO
- Regulation
- 870.2380
- Classification name
- cardiovascular machine learning-based notification software
- Decision
- granted (DENG)
- Decision date
- 2023-08-03
- Date received
- 2023-01-10
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QXO
- Device name
- Cardiovascular Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.2380
- Implant
- N
- Life sustain/support
- N