K232616
- 510(k) number
- K232616
- Device name
- Volta AF-Xplorer
- Applicant
- Volta Medical FR
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2023-09-27
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232616.pdf
Official FDA record: K232616
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.