510(k) K030341 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
| Applicant | eVent Medical, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Jan 16, 2004 |
| Received | Feb 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030341
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.