K232294
- 510(k) number
- K232294
- Device name
- HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2023-10-31
- Date received
- 2023-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K232294.pdf
Official FDA record: K232294
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.