510(k) K082866 ยท BZD Ventilator, Non-Continuous (Respirator)
REVOLUTIONFULL FACE MASK
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Jan 30, 2009 |
| Received | Sep 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2022 | Philips Respironics, Inc. Philips Respironics Amara View Minimal Contact Full-Face Mask Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.