FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Sepsis ImmunoScore
K Number: DEN230036
·
Decision Apr 2, 2024
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
1
Review Days
333
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Basic Information
- Device Name
- Sepsis ImmunoScore
- K Number
- DEN230036
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 880.6316
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Prenosis, Inc.
- Date Received
- May 5, 2023
- Decision Date
- April 2, 2024
- Product Code
- SAK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SAK | Software Device To Aid In The Prediction Or Diagnosis Of Sepsis | FDA class 2 | General Hospital |
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