K240795
- 510(k) number
- K240795
- Device name
- Withings ECG App
- Applicant
- Withings FR
- Product code
- QDA — Electrocardiograph Software For Over-The-Counter Use
- Decision date
- 2025-06-15
- Date received
- 2024-03-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240795.pdf
Official FDA record: K240795
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.