510(k) K251631 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
The BAG manual resuscitator and accessories
| Applicant | Laerdal Medical AS, Stavanger, NO |
| Decision | Substantially Equivalent, Nov 24, 2025 |
| Received | May 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251631
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.