eCARTv5 Clinical Deterioration Suite (eCART)
FDA 510(k) K233253 · Agilemd, Inc.
Submission
- Device name
- eCARTv5 Clinical Deterioration Suite (eCART)
- Applicant
- Agilemd, Inc.
San Francisco, CA, US - Received
- September 28, 2023
- Decision date
- June 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNL – Medium-Term Adjunctive Predictive Cardiovascular Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2210
- Specialty
- 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.
Other 510(k)s with product code QNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was eCARTv5 Clinical Deterioration Suite (eCART) cleared by the FDA?
eCARTv5 Clinical Deterioration Suite (eCART) (K233253) received a 510(k) decision of Substantially Equivalent on June 21, 2024, 267 days after the submission was received.
What is the product code of K233253?
The FDA product code is QNL – Medium-Term Adjunctive Predictive Cardiovascular Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2210.