K262006
- 510(k) number
- K262006
- Device name
- EnSite X EP System
- Applicant
- Abbott Medical MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-07-15
- Date received
- 2026-06-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K262006.pdf
Official FDA record: K262006
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.