K232445
- 510(k) number
- K232445
- Device name
- CSF-4 (CSF-4)
- Applicant
- Cardiacsense IL
- Product code
- DPS — Electrocardiograph
- Decision date
- 2024-05-02
- Date received
- 2023-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232445.pdf
Official FDA record: K232445
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.