510(k) K053142 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU MARK IV BABY RESUSCITATOR
| Applicant | Ambu A/S, Glen Burnie MD, US |
| Decision | Substantially Equivalent, Dec 20, 2005 |
| Received | Nov 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053142
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.