510(k) K071527 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
PNEUPAC VR1 AIR MIX
| Applicant | Smiths Medical International , Ltd., Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 4, 2007 |
| Received | Jun 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071527
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.