510(k) DEN230036
- Device
- Sepsis ImmunoScore
- Applicant
- Prenosis, Inc.
- 510(k) number
- DEN230036
- Product code
- SAK
- Decision
- Unknown (DENG)
- Decision date
- 2024-04-02
- Date received
- 2023-05-05
- Regulation
- 880.6316
- Classification name
- Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Bobby Reddy
- Address
- 3440 S Dearborn St., Suite 222s Chicago IL US 60616 60616
FDA Registration Numbers#
- 3014456004
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SAK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250680 | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | 2026-04-30 |