K253186
- 510(k) number
- K253186
- Device name
- HemoSphere Nano Monitor (HSNANO1)
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-02-24
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253186.pdf
Official FDA record: K253186
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.