K250680
- 510(k) number
- K250680
- Device name
- Bayesian Health Sepsis Flagging Device
- Applicant
- Bayesian Health, Inc. NY · US
- Product code
- SAK — Software Device To Aid In The Prediction Or Diagnosi
- Decision date
- 2026-04-30
- Date received
- 2025-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250680.pdf
Official FDA record: K250680
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.