510(k) K230842
- Device
- SignalHF (IM008)
- Applicant
- Implicity, Inc.
- 510(k) number
- K230842
- Product code
- QNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-25
- Date received
- 2023-03-28
- 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
- Caroline Florequin
- Address
- 185 Alewife Brook Pkwy., Suite 210 Cambridge MA US 02138 02138
FDA Registration Numbers#
- 3030125003
- 3006104191
- 3004832480
- 3031823069
- 2133641
- 3032916632
- 9615817
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 |
| K233216 | CLEWICU System | Clew Medical , Ltd. | 2024-01-13 |
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023-07-26 |
| K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical , Ltd. | 2021-01-09 |