CLEWICU System (ClewICUServer and ClewICUnitor)
FDA 510(k) K200717 · Clew Medical , Ltd.
Submission
- Device name
- CLEWICU System (ClewICUServer and ClewICUnitor)
- Applicant
- Clew Medical , Ltd.
Netanya, IL - Received
- March 18, 2020
- Decision date
- January 9, 2021
- 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 |
|---|---|---|---|
| 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 |
More from Edwards Lifesciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K233216 | CLEWICU SystemQNL · Traditional | 01/13/2024SE |
Questions and answers
When was CLEWICU System (ClewICUServer and ClewICUnitor) cleared by the FDA?
CLEWICU System (ClewICUServer and ClewICUnitor) (K200717) received a 510(k) decision of Substantially Equivalent on January 9, 2021, 297 days after the submission was received.
What is the product code of K200717?
The FDA product code is QNL – Medium-Term Adjunctive Predictive Cardiovascular Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2210.