510(k) K142554 ยท BZD Ventilator, Non-Continuous (Respirator)
Revolution Full Face Mask
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jan 9, 2015 |
| Received | Sep 11, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K142554
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2022 | Philips Respironics, Inc. Philips Respironics DreamWear 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.