510(k) K213488 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Bladder Scanner, Model Name:M5
| Applicant | Suzhou Peaksonic Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jul 1, 2022 |
| Received | Nov 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213488
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.