K252978
- 510(k) number
- K252978
- Device name
- ScioCardio ECG Analysis Platform
- Applicant
- Synergen Technology Labs, LLC TX · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-07-09
- Date received
- 2025-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K252978.pdf
Official FDA record: K252978
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.