510(k) K082268 ยท DQA Oximeter
CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
| Applicant | Oridion Capnography, Inc., Jerusalem, IL |
| Decision | Substantially Equivalent, Feb 6, 2009 |
| Received | Aug 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (US) N, Part Number CS08651 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657 Terminated |
CCK | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M, Part Number CS08653 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER, Part Number CS08659 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M TO MASIMO, Part Number CS08750 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US)M REFURBISHED, Part Number CS78653 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659 Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.