510(k) K233216
- Device
- CLEWICU System
- Applicant
- Clew Medical , Ltd.
- 510(k) number
- K233216
- Product code
- QNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-13
- Date received
- 2023-09-28
- Regulation
- 870.2210
- Classification name
- Medium-Term Adjunctive Predictive Cardiovascular Indicator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Avidgor Faians
- Address
- 5 Hamelecha St. Poleg IL 4250540 4250540
FDA Registration Numbers#
- 9615817
- 3031823069
- 2015691
- 3004832480
- 3032916632
- 3006104191
- 2133641
- 3030125003
Source Documents#
Other 510(k) Records For Product Code QNL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024-06-21 |
| K230842 | SignalHF (IM008) | Implicity, Inc. | 2023-10-25 |
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023-07-26 |
| K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical , Ltd. | 2021-01-09 |