510(k) K040485 ยท FYA Gown, Surgical
MAXAIR SURGICAL HELMET SYSTEM
| Applicant | Bio-Medical Devices, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 18, 2004 |
| Received | Feb 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 Open, Classified |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.