CLEWICU System (ClewICUServer and ClewICUnitor)
FDA 510(k) clearance K200717 · decided 2021-01-09
Clearance details
- K-number
- K200717
- Device name
- CLEWICU System (ClewICUServer and ClewICUnitor)
- Applicant
- Clew Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-18
- Decision date
- 2021-01-09
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- QNL
- Device class
- 2
- Regulation number
- 870.2210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Netanya, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Clew Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.