K260343
- 510(k) number
- K260343
- Device name
- Carescape Canvas 1000; Carescape Canvas Smart Display
- Applicant
- GE Healthcare Finland Oy FI
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2026-08-28
- Date received
- 2026-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K260343.pdf
Official FDA record: K260343
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.