510(k) K131877 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
SAVE II, SAVE II BASIC
| Applicant | Automedx, Inc., Flower Mound TX, US |
| Decision | Substantially Equivalent, Mar 21, 2014 |
| Received | Jun 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131877
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.