510(k) K172035 ยท JXG Shunt, Central Nervous System And Components
EKOS ultrasound EVD Device, EVD Control Unit
| Applicant | Btg International, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Mar 24, 2018 |
| Received | Jul 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172035
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.