K233216
- 510(k) number
- K233216
- Device name
- CLEWICU System
- Applicant
- Clew Medical , Ltd. IL
- Product code
- QNL — Medium-Term Adjunctive Predictive Cardiovascular Ind
- Decision date
- 2024-01-13
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233216.pdf
Official FDA record: K233216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.