510(k) K012394 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Aug 15, 2001 |
| Received | Jul 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012394
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.