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De Novo DEN230036
- Device
- Sepsis ImmunoScore
- Contact
- bobby reddy
- De Novo number
- DEN230036
- Product code
- SAK
- Regulation
- 880.6316
- Classification name
- software device to aid in the prediction or diagnosis of sepsis
- Decision
- granted (DENG)
- Decision date
- 2024-04-02
- Date received
- 2023-05-05
- Classification advisory
- General Hospital
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- SAK
- Device name
- Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6316
- Implant
- N
- Life sustain/support
- N