K230919
- 510(k) number
- K230919
- Device name
- Acumen IQ finger cuff
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2023-10-24
- Date received
- 2023-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K230919.pdf
Official FDA record: K230919
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.