510(k) K182956 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Puffin Lite Infant Resuscitation System
| Applicant | International Biomedical, Austin TX, US |
| Decision | Substantially Equivalent, Jan 18, 2019 |
| Received | Oct 24, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182956
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.