510(k) K112368 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CAPNOSTREAM20P WITH AI/ODI
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Jul 19, 2012 |
| Received | Aug 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N, Part Number CS08651-01 Terminated |
CCK | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02 Terminated |
CCK | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01 Terminated |
CCK | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.