510(k) K103434 ยท BZD Ventilator, Non-Continuous (Respirator)
3B FLEX-LITE
| Applicant | 3B Products, LLC, Lake Wales FL, US |
| Decision | Substantially Equivalent, Oct 13, 2011 |
| Received | Nov 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103434
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.