510(k) K192611 ยท BSK Cuff, Tracheal Tube, Inflatable
Cuffix
| Applicant | Biovo Technologies , Ltd., Rosh Haayin, IL |
| Decision | Substantially Equivalent, Aug 13, 2020 |
| Received | Sep 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192611
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.