510(k) K011050 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, May 4, 2001 |
| Received | Apr 6, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011050
| 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 SMART CAPNOLINE PLUS ADU/INT 25UN
Part Number: 009818 Oridion
3012176-011 Physio Control Terminated |
CCK | None listed |
| Jul 13, 2010 | Oridion Medical 1987 Ltd. Microstream SMART CAPNOLINE PLUS 100 UN
Part Number: 010209 Oridion
3012176-111 Physio Control Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.