QNL
5 FDA 510(k) clearances · Product code
211 daysmedian time to decision
297 days90th percentile
5clearances measured
FDA profile
- Official device name
- Medium-Term Adjunctive Predictive Cardiovascular Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2210
- Medical specialty
- Cardiovascular
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| eCARTv5 Clinical Deterioration Suite (“eCART”) (K233253) | Agilemd, Inc. | 2024-06-21 |
| CLEWICU System (K233216) | Clew Medical , Ltd. | 2024-01-13 |
| SignalHF (IM008) (K230842) | Implicity, Inc. | 2023-10-25 |
| Global Hypoperfusion Index (GHI) Algorithm (K231038) | Edwards Lifesciences, LLC | 2023-07-26 |
| CLEWICU System (ClewICUServer and ClewICUnitor) (K200717) | Clew Medical , Ltd. | 2021-01-09 |
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Every clearance here is in the API, with alerts when new ones post.