510(k) K851462 ยท BTO Tube, Tracheostomy (W/Wo Connector)
BFW VOICE GENERATOR
| Applicant | Bfw Laboratories, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, May 28, 1985 |
| Received | Apr 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851462
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.