510(k) K162968 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
VORTRAN GO2VENT
| Applicant | Vortran Medical Technology 1, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Apr 10, 2017 |
| Received | Oct 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162968
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.