510(k) K231889 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
| Applicant | Ultrasound Biotechnology (Shanghai) Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Dec 21, 2023 |
| Received | Jun 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231889
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.