Panels › General Hospital › Product code SAK · Class 2
Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Regulation 880.6316
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SAK
| Company | 510(k)s | Recalls |
|---|---|---|
| Bayesian Health, Inc. | 1 | 0 |
| Prenosis, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2026 | K250680 | Bayesian Health Sepsis Flagging Device Bayesian Health, Inc. | SAK |
| Apr 2, 2024 | DEN230036 | Sepsis ImmunoScore Prenosis, Inc. | SAK |
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