FDA Product Code
FDA Product Code QNL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2210
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260008 | Deterioration Index Version 2 | Epic Systems Corporation | 2026-09-18 | Traditional | PDF ↗ |
| K233253 | eCARTv5 Clinical Deterioration Suite (eCART) | Agilemd, Inc. | 2024-06-21 | Traditional | PDF ↗ |
| K233216 | CLEWICU System | Clew Medical , Ltd. | 2024-01-13 | Traditional | PDF ↗ |
| K230842 | SignalHF (IM008) | Implicity, Inc. | 2023-10-25 | Traditional | PDF ↗ |
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023-07-26 | Traditional | PDF ↗ |
| K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical , Ltd. | 2021-01-09 | Traditional | PDF ↗ |
Product code QNL · Class II · Cardiovascular. Data: openFDA.