510(k) K091947 ยท BZD Ventilator, Non-Continuous (Respirator)
S8 ASPEN WITH H4I PLUS
| Applicant | Resmed, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 28, 2009 |
| Received | Jun 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091947
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.