510(k) K010024 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
O2/CO2 NASAL FILTERLINE
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Mar 14, 2001 |
| Received | Jan 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2012 | Oridion Medical 1987 Ltd. Oridion CO2 sampling lines and water traps under the label:
MicroStreamC02 Sampling Lines:
FilterLine Set Adult/Pediatric -Part No: XS04620-01;
FilterLine Set Adult/Pediatric (100 unit boxes)-Part Terminated |
CCK | None listed |
| Jul 13, 2010 | Oridion Medical 1987 Ltd. Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN
Part Number: 006912 Terminated |
CCK | None listed |
| Jul 13, 2010 | Oridion Medical 1987 Ltd. Microstream CAPNOLINE H O2 ADULT 25UN
Part Number: 008180 Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.