510(k) K191858 ยท BSK Cuff, Tracheal Tube, Inflatable
Pylant Monitor
| Applicant | Kal-Med, LLC, Kensington CT, US |
| Decision | Substantially Equivalent, Feb 24, 2020 |
| Received | Jul 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191858
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.