510(k) K012271 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
ACUTEVENTILATOR
| Applicant | Impoex International, Ltd., Little River SC, US |
| Decision | Substantially Equivalent, Oct 4, 2002 |
| Received | Jul 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012271
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.