510(k) K252078 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BreathePal Bilevel (GFM50-MD2201)
| Applicant | Compal Electronics, Inc., Taipei City, TW |
| Decision | Substantially Equivalent, Mar 17, 2026 |
| Received | Jul 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252078
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.