510(k) K173373 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
SafeT T-Piece Resuscitator
| Applicant | Ventlab, LLC, Grand Rapids MI, US |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Oct 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173373
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.