510(k) K061874 ยท BZD Ventilator, Non-Continuous (Respirator)
INVACARE'S TWILIGHT II NASAL MASKS
| Applicant | Invacare Corp., Elyria OH, US |
| Decision | Substantially Equivalent, Sep 5, 2006 |
| Received | Jul 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061874
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.