510(k) K152778 ยท BSK Cuff, Tracheal Tube, Inflatable
TRACOE Cuff Pressure Monitor
| Applicant | Tracoe Medical GmbH, Nieder-Olm, DE |
| Decision | Substantially Equivalent, Dec 21, 2016 |
| Received | Sep 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152778
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.