510(k) K991648 ยท BZD Ventilator, Non-Continuous (Respirator)
REUSABLE CONTOUR II NASAL MASK
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, May 28, 1999 |
| Received | May 13, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991648
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.