510(k) K854458 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
CUSHION-FLEX TM-CPAP FACE MASK
| Applicant | Life Design Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jan 15, 1986 |
| Received | Nov 6, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854458
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.