510(k) K121747 ยท BZD Ventilator, Non-Continuous (Respirator)
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
| Applicant | Intersurgical Incorporated, Liverpool NY, US |
| Decision | Substantially Equivalent, Mar 14, 2013 |
| Received | Jun 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121747
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.