QNL — Medium-Term Adjunctive Predictive Cardiovascular Indicator Class II
FDA product code QNL covers "Medium-Term Adjunctive Predictive Cardiovascular Indicator", a Class II medical device regulated under 21 CFR 870.2210. Submissions are reviewed by the Cardiovascular panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QNL
- Device Class
- Class II
- Regulation Number
- 870.2210
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233253 | agilemd | eCARTv5 Clinical Deterioration Suite (eCART) | June 21, 2024 |
| K233216 | clew medical | CLEWICU System | January 13, 2024 |
| K230842 | implicity | SignalHF (IM008) | October 25, 2023 |
| K231038 | edwards lifesciences | Global Hypoperfusion Index (GHI) Algorithm | July 26, 2023 |
| K200717 | clew medical | CLEWICU System (ClewICUServer and ClewICUnitor) | January 9, 2021 |