510(k) K040011 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
POLARIS 2004 CAPNOGRAPH
| Applicant | Oridion , Ltd., Needham MA, US |
| Decision | Substantially Equivalent, May 13, 2004 |
| Received | Jan 5, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040011
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.