K240909
- 510(k) number
- K240909
- Device name
- Samsung ECG App v 1.3 (ECG)
- Applicant
- Samsung Electronics Co., Ltd. KR
- Product code
- QDA — Electrocardiograph Software For Over-The-Counter Use
- Decision date
- 2024-08-02
- Date received
- 2024-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K240909.pdf
Official FDA record: K240909
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.