510(k) K161605 ยท JXG Shunt, Central Nervous System And Components
Smart External Drain (SED) System
| Applicant | Aqueduct Critical Care, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Oct 27, 2016 |
| Received | Jun 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161605
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.