510(k) K180991 ยท BSK Cuff, Tracheal Tube, Inflatable
AG 100s
| Applicant | Hospitech Respiration , Ltd., Petach Tikva, IL |
| Decision | Substantially Equivalent, Oct 12, 2018 |
| Received | Apr 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180991
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.