K250228
- 510(k) number
- K250228
- Device name
- eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)
- Applicant
- Esonic Technology (Wuhan) Co., Ltd. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-04-23
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250228.pdf
Official FDA record: K250228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.