K230842
- 510(k) number
- K230842
- Device name
- SignalHF (IM008)
- Applicant
- Implicity, Inc. MA · US
- Product code
- QNL — Medium-Term Adjunctive Predictive Cardiovascular Ind
- Decision date
- 2023-10-25
- Date received
- 2023-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K230842.pdf
Official FDA record: K230842
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.