510(k) K043495 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
BABYPAC
| Applicant | Smiths Medical International Ltd., Luton, Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 22, 2005 |
| Received | Dec 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043495
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.