K241051
- 510(k) number
- K241051
- Device name
- Vave Wireless Ultrasound System
- Applicant
- Vave Health, Inc. CA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-08-30
- Date received
- 2024-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241051.pdf
Official FDA record: K241051
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.