510(k) K160822 ยท BZD Ventilator, Non-Continuous (Respirator)
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
| Applicant | Resmed, Ltd., Bella Vista, AU |
| Decision | Substantially Equivalent, Sep 9, 2016 |
| Received | Mar 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160822
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.