K252474
- 510(k) number
- K252474
- Device name
- Withings BeamO (SCT02)
- Applicant
- Withings FR
- Product code
- DPS — Electrocardiograph
- Decision date
- 2025-11-10
- Date received
- 2025-08-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K252474.pdf
Official FDA record: K252474
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.