510(k) K221634 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Oxymag - Transport and Emergency Ventilator
| Applicant | Magnamed Tecnologia Medica S/A, Cotia, BR |
| Decision | Substantially Equivalent, May 24, 2023 |
| Received | Jun 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221634
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.