510(k) K123979 ยท BZD Ventilator, Non-Continuous (Respirator)
QUATTRO AIR
| Applicant | Resmed, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 27, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2016 | Resmed Corporation Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.