510(k) K171591 · IYO System, Imaging, Pulsed Echo, Ultrasonic
CUBEScan BioCon-900 (Bladder Volume Measurement System)
| Applicant | Mcube Technology Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jun 22, 2017 |
| Received | May 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171591
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.