510(k) K260008
- Device
- Deterioration Index Version 2
- Applicant
- Epic Systems Corporation
- 510(k) number
- K260008
- Product code
- QNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-18
- Date received
- 2026-01-02
- Regulation
- 870.2210
- Classification name
- Medium-Term Adjunctive Predictive Cardiovascular Indicator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Brian Jacobson
- Address
- 1979 Milky Way Verona WI US 53593 53593
FDA Registration Numbers#
- 9615817
- 2133641
- 3031823069
- 3045891669
- 3006104191
- 3030125003
- 3032916632
- 3004832480
Source Documents#
Other 510(k) Records For Product Code QNL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024-06-21 |
| K233216 | CLEWICU System | Clew Medical , Ltd. | 2024-01-13 |
| K230842 | SignalHF (IM008) | Implicity, Inc. | 2023-10-25 |
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023-07-26 |
| K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical , Ltd. | 2021-01-09 |