Medium-Term Adjunctive Predictive Cardiovascular Indicator
FDA product code QNL · Class II (moderate risk) · 21 CFR 870.2210 · Cardiovascular
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233253 | eCARTv5 Clinical Deterioration Suite (eCART)QNL · Traditional | Agilemd, Inc. | 06/21/2024SE |
| K233216 | CLEWICU SystemQNL · Traditional | Clew Medical , Ltd. | 01/13/2024SE |
| K230842 | SignalHF (IM008)QNL · Traditional | Implicity, Inc. | 10/25/2023SE |
| K231038 | Global Hypoperfusion Index (GHI) AlgorithmQNL · Traditional | Edwards Lifesciences, LLC | 07/26/2023SE |
| K200717 | CLEWICU System (ClewICUServer and ClewICUnitor)QNL · Traditional | Clew Medical , Ltd. | 01/09/2021SE |