K252533
- 510(k) number
- K252533
- Device name
- HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-12-18
- Date received
- 2025-08-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K252533.pdf
Official FDA record: K252533
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.