510(k) K201316 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
| Applicant | Suzhou Peaksonic Medical Technology Co., Ltd., Qiandeng, Kunshan, Suzhou, CN |
| Decision | Substantially Equivalent, Feb 26, 2021 |
| Received | May 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201316
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.