K252013
- 510(k) number
- K252013
- Device name
- EnSite X EP System
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-09-25
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252013.pdf
Official FDA record: K252013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.