K243566
- 510(k) number
- K243566
- Device name
- CardioTag
- Applicant
- Cardiosense, Inc. IL · US
- Product code
- DXR — Ballistocardiograph
- Decision date
- 2025-07-22
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243566.pdf
Official FDA record: K243566
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.