510(k) K150638 ยท CBK Ventilator, Continuous, Facility Use
AF541 SE Full Face Mask
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Sep 18, 2015 |
| Received | Mar 11, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K150638
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.