Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
- US Product Code (FDA)
- SAKView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 880.6316View CFR Regulation →
- Medical specialty
- General Hospital
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis.
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Software Device To Aid In The Prediction Or Diagnosis Of Sepsis is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.