510(k) K172356 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
BladderScan Prime PLUS System
| Applicant | Verathon Incorporated, Bothell WA, US |
| Decision | Substantially Equivalent, Sep 15, 2017 |
| Received | Aug 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172356
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2020 | Verathon, Inc. BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively. Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.