510(k) K181583 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 4
| Applicant | Flexicare Medical Limited., Mountain Ash, GB |
| Decision | Substantially Equivalent, Dec 7, 2018 |
| Received | Jun 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181583
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.