510(k) K123535 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ILAB ULTRASOUND IMAGING SYSTEM
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Jan 15, 2013 |
| Received | Nov 16, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123535
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.