510(k) K030563 ยท BZD Ventilator, Non-Continuous (Respirator)
ARABELLA NCPAP MASKS
| Applicant | Hamilton Medical AG, Reno NV, US |
| Decision | Substantially Equivalent, Sep 9, 2003 |
| Received | Feb 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030563
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.