510(k) K161263 ยท DXO Transducer, Pressure, Catheter Tip
OptoMonitor II
| Applicant | Opsens, Inc., Quebec, CA |
| Decision | Substantially Equivalent, Sep 13, 2016 |
| Received | May 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161263
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.