DeviceClearance

Bayesian Health Sepsis Flagging Device— 510(k) K250680

Substantially Equivalent

Bayesian Health, Inc.

FDA 510(k) clearance K250680 for Bayesian Health Sepsis Flagging Device, Substantially Equivalent on 2026-04-30. Applicant: Bayesian Health, Inc..

Clearance details

Applicant
Bayesian Health, Inc.
Product code
Code SAK
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.