510(k) K060065 ยท DQA Oximeter
CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
| Applicant | Oridion Capnography, Inc., Jerusalem, IL |
| Decision | Substantially Equivalent, May 4, 2006 |
| Received | Jan 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2009 | Oridion Medical 1987 Ltd. Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659. Terminated |
CCK | None listed |
| Nov 28, 2007 | Oridion Capnography Inc Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical Terminated |
DQA | None listed |
| Nov 28, 2007 | Oridion Capnography Inc Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.