510(k) K103395 ยท BZD Ventilator, Non-Continuous (Respirator)
PERFORMAX TOTAL FACE MASK
| Applicant | Respironics, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Mar 24, 2011 |
| Received | Nov 19, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103395
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.