510(k) K884089 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
ERA 2000 EMERGENCY RESUSCITATOR
| Applicant | Neotronics Medical , Ltd., Bishop'S Stortford, GB |
| Decision | Substantially Equivalent, Dec 20, 1988 |
| Received | Sep 28, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884089
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.