510(k) K070746 ยท BZD Ventilator, Non-Continuous (Respirator)
RESTRAXX DATA CENTRE, MODEL R10
| Applicant | Resmed, Ltd., Poway CA, US |
| Decision | Substantially Equivalent, Jul 13, 2007 |
| Received | Mar 19, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070746
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.