510(k) K042556 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
| Applicant | Enter Medical Corporation, Gui Shan Xiang,Tao Yuan Hsien, TW |
| Decision | Substantially Equivalent, Mar 11, 2005 |
| Received | Sep 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042556
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.