K232048
- 510(k) number
- K232048
- Device name
- Cogent Hemodynamic Monitoring System; Cogent HMS
- Applicant
- Icu Medical CA · US
- Product code
- DXG — Computer, Diagnostic, Pre-Programmed, Single-Functio
- Decision date
- 2023-12-20
- Date received
- 2023-07-10
- 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: K232048.pdf
Official FDA record: K232048
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.