510(k) K210386 ยท BZD Ventilator, Non-Continuous (Respirator)
Magneto Nasal Mask
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jul 12, 2021 |
| Received | Feb 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210386
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2022 | Philips Respironics, Inc. Therapy Mask 3100 NC/SP Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.