510(k) K041524 ยท CBK Ventilator, Continuous, Facility Use
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Sep 20, 2004 |
| Received | Jun 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041524
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.