510(k) K132887 ยท BZD Ventilator, Non-Continuous (Respirator)
AIRFIT N10
| Applicant | Resmed, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Sep 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132887
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2023 | ResMed Ltd. AirFit N10 Nasal Masks and User Guide Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.