510(k) K043085 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO: PNEUTON VENTILATOR
| Applicant | Airon Corporation, Melbourne FL, US |
| Decision | Substantially Equivalent, Dec 20, 2004 |
| Received | Nov 8, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043085
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.