K252463
- 510(k) number
- K252463
- Device name
- SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- Applicant
- Edan Instruments, Inc. CN
- Product code
- DPS — Electrocardiograph
- Decision date
- 2026-07-02
- Date received
- 2025-08-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252463.pdf
Official FDA record: K252463
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.