510(k) K140580 ยท BZD Ventilator, Non-Continuous (Respirator)
REVOLUTION FULLFACE MASK
| Applicant | Respironics Inc. (Dba Philips Respironics), Murrysville PA, US |
| Decision | Substantially Equivalent, Jan 16, 2015 |
| Received | Mar 6, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140580
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.