510(k) K111347 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ISROBOT MONA LISA
| Applicant | Biobot Surgical Pte., Ltd., Alexandria VA, US |
| Decision | Substantially Equivalent, Aug 12, 2011 |
| Received | May 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111347
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.