510(k) K161978 ยท BZD Ventilator, Non-Continuous (Respirator)
AirFit N20
| Applicant | Resmed, Ltd., Bella Vista, AU |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Jul 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2023 | ResMed Ltd. AirTouch N20 Nasal Mask 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.