K252361
- 510(k) number
- K252361
- Device name
- AccurECG Analysis System (v2.0)
- Applicant
- Accurkardia, Inc. NY · US
- Product code
- DPS — Electrocardiograph
- Decision date
- 2025-12-22
- Date received
- 2025-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K252361.pdf
Official FDA record: K252361
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.