Global Hypoperfusion Index (GHI) Algorithm
FDA 510(k) clearance K231038 · decided 2023-07-26
Clearance details
- K-number
- K231038
- Device name
- Global Hypoperfusion Index (GHI) Algorithm
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-04-12
- Decision date
- 2023-07-26
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- QNL
- Device class
- 2
- Regulation number
- 870.2210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edwards Lifesciences
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 |
| CLEWICU System (ClewICUServer and ClewICUnitor) (K200717) | Clew Medical , Ltd. | 2021-01-09 |
Recalls involving this device
No recalls on record reference this clearance.