eCARTv5 Clinical Deterioration Suite (“eCART”)
FDA 510(k) clearance K233253 · decided 2024-06-21
Clearance details
- K-number
- K233253
- Device name
- eCARTv5 Clinical Deterioration Suite (“eCART”)
- Applicant
- Agilemd, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2024-06-21
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- QNL
- Device class
- 2
- Regulation number
- 870.2210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| CLEWICU System (ClewICUServer and ClewICUnitor) (K200717) | Clew Medical , Ltd. | 2021-01-09 |
Recalls involving this device
No recalls on record reference this clearance.