K251463
- 510(k) number
- K251463
- Device name
- EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-09-04
- Date received
- 2025-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251463.pdf
Official FDA record: K251463
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.