K223812
- 510(k) number
- K223812
- Device name
- Sensis Vibe (VD15)
- Applicant
- Siemens Medical Solutions USA, Inc. PA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2023-09-15
- Date received
- 2022-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K223812.pdf
Official FDA record: K223812
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.