510(k) K112852 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
BABI PLUS NEONATAL RESUSCITATION BAG
| Applicant | A Plus Medical, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jan 13, 2012 |
| Received | Oct 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112852
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.