510(k) K042294 ยท BZD Ventilator, Non-Continuous (Respirator)
SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
| Applicant | Suiter Enterprises, Inc., Auburn WA, US |
| Decision | Substantially Equivalent, Sep 10, 2004 |
| Received | Aug 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042294
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.