510(k) K102824 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
| Applicant | Ambu A/S, Glen Burnie MD, US |
| Decision | Substantially Equivalent, Jan 28, 2011 |
| Received | Sep 29, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K102824
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.