510(k) K213411 · IYO System, Imaging, Pulsed Echo, Ultrasonic
iSRobot Mona Lisa 2.0
| Applicant | Biobot Surgical Pte., Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Dec 22, 2021 |
| Received | Oct 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213411
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.