510(k) K243513 ยท LEL Device, Sleep Assessment
DCM (PW-DCM)
| Applicant | Pneumowave, Ltd., Eurocentral, GB |
| Decision | Substantially Equivalent, Apr 16, 2025 |
| Received | Nov 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243513
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.