K243312
- 510(k) number
- K243312
- Device name
- CER-S
- Applicant
- Cardiocalm Srl IT
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-02-20
- Date received
- 2024-10-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K243312.pdf
Official FDA record: K243312
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.