510(k) K081440 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
| Applicant | Smiths Medical Asd, Inc., Dublin OH, US |
| Decision | Substantially Equivalent, Sep 12, 2008 |
| Received | May 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2020 | Smiths Medical ASD Inc. Pediatric Adjustable Flange Tracheostomy Tube Cuffless Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.