K233326
- 510(k) number
- K233326
- Device name
- Merge Hemo, Model RCSV2
- Applicant
- Merge Healthcare Incorporated WI · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-06-21
- Date received
- 2023-09-29
- 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: K233326.pdf
Official FDA record: K233326
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.