510(k) K153369 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 22, 2015 |
| Received | Nov 23, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153369
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.