K231889
- 510(k) number
- K231889
- Device name
- Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
- Applicant
- Ultrasound Biotechnology (Shanghai) Co., Ltd. CN
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2023-12-21
- Date received
- 2023-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231889.pdf
Official FDA record: K231889
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.