K242662
- 510(k) number
- K242662
- Device name
- Falcon/Xpress (Falcon/Xpress)
- Applicant
- Viasonix , Ltd. IL
- Product code
- JOP — Transducer, Ultrasonic
- Decision date
- 2024-12-18
- Date received
- 2024-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242662.pdf
Official FDA record: K242662
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.