510(k) K821568 ยท EWL Prosthesis, Laryngeal (Taub)
BLOW-SINGER TRACHEOSTOMA VALVE
| Applicant | Bivona Medical Technologies, Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 26, 1982 |
| Received | May 27, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821568
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2013 | Helix Medical LLC Blom-Singer Adjustable Tracheostoma Valve II
Models: BE8025H and BE8025H-R3 Terminated |
EWL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.