510(k) K911261 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
ERA 2000A
| Applicant | Neotronics, Inc., Gainesville GA, US |
| Decision | Substantially Equivalent, May 31, 1991 |
| Received | Mar 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911261
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.