510(k) K123690 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CAPNOSTREAM20P WITH HIFI C02 MONITORING
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Aug 5, 2014 |
| Received | Dec 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123690
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2016 | Medtronic Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520.
Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monito Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.